- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02893878
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Surrey, United Kingdom, GU2 7XH
- GSK Investigational Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.
Exclusion Criteria:
• In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vaccinated_Fluarix Tetra Group
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in approximately 10 volunteer practices.
|
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
|
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in approximately 10 volunteer practices.
|
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
|
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in approximately 10 volunteer practices.
|
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Local symptoms include local erythema.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Local symptoms include local erythema.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Rash AEs include any rash AEs, generalised rash and rash.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Rash AEs include any rash AEs, generalised rash and rash.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Local symptoms included local erythema.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Local symptoms included local erythema.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
- Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Rash AEs include any rash AEs, generalised rash and rash.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Rash AEs include any rash AEs, generalised rash and rash.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
AEIs were presented by categories depending of the nature of the event.
-Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Rash AEs include any rash AEs, generalised rash and rash.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Rash AEs include any rash AEs, generalised rash and rash.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Time Frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
|
Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202056
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