Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.

October 16, 2023 updated by: GlaxoSmithKline

Assessment of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information in Korea.

The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adults and previously vaccinated children aged ≥6 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 6 months to less than (<) 9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local PI in Korea.

Fluarix Tetra may be administered to pregnant women/lactating women as per PI, if there is a clear need. Pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 47545
        • GSK Investigational Site
      • Daegu, Korea, Republic of, 42274
        • GSK Investigational Site
      • Daegu, Korea, Republic of, 700 712
        • GSK Investigational Site
      • Daegu-si, Korea, Republic of, 42601
        • GSK Investigational Site
      • Donghae, Korea, Republic of, 25768
        • GSK Investigational Site
      • Gwangmyeong, Korea, Republic of, 484 5
        • GSK Investigational Site
      • Gyeongsangbuk-do, Korea, Republic of, 39230
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 22214
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03966
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 04143
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 04168
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 138201
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03722
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03181
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 06568
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 08737
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 7499
        • GSK Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16388
        • GSK Investigational Site
      • Ulsan, Korea, Republic of, 683380
        • GSK Investigational Site
      • Yangju-si, Gyeonggi-do, Korea, Republic of, 11456
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects aged 6 months and above who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra in Korea according to the locally approved PI.

Description

Inclusion Criteria:

  • Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.
  • Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject's parent(s)/Legally acceptable Representative(s) [LAR(s)].

Exclusion Criteria:

  • Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.

    • Hypersensitivity reaction to Fluarix Tetra.
    • History of hypersensitivity reaction to Influenza vaccine.
    • History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination.
  • Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Fluarix Tetra Group 1
Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Other: Data collection
Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.
Fluarix Tetra Group 2
Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Other: Data collection
Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Expected Adverse Events (AEs)
Time Frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.
During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Number of Participants With Unexpected Adverse Events (AEs)
Time Frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.
During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.
During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 204687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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