- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161160
Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old
August 9, 2018 updated by: GlaxoSmithKline
An Observer-blind Safety and Immunogenicity Study of GSK Biologicals' A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340272A in Children 3 to Less Than 10 Years Old
This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
209
Phase
- Phase 2
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
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Sampaloc, Manila, Philippines, 1008
- GSK Investigational Site
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Bangkok, Thailand, 10400
- GSK Investigational Site
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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
Ages Eligible for Study
3 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or pre-menarchal female children 3 to < 10 years of age at the time of the study vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of the study vaccine dose under this protocol.
- Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- Good general health as established by medical history and clinical examination before entering into the study.
- Subjects and/or parent(s)/LAR who the investigator believes can and will comply with the requirements of the protocol as documented by signature on the informed consent document (and, if appropriate, the informed assent document).
Exclusion Criteria:
- Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- Presence of a temperature ≥ 38.0ºC by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment (day of study vaccination), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
- Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- Administration of any licensed live-attenuated vaccine within 30 days before study vaccination or any licensed inactivated vaccine within 15 days before study vaccination.
- Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 21 phlebotomy.
- Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 21. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding study vaccination, or planned use during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Child in care (A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts).
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AREPANRIX 1/2 GROUP
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
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Intramuscular injection
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Experimental: PANDEMRIX 1/2 GROUP
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
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Intramuscular injection
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Experimental: AREPANRIX GROUP
Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
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Intramuscular injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 21
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Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (>) 40%.
The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.
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At Day 21
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Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 0
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%.
The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
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At Day 0
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Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 21
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%.
The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
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At Day 21
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 21
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GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
The CHMP criterion was fulfilled if the point estimate for GMFR was > 2.5.
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At Day 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 182
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Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was > 40%.
The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was > 40%.
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At Day 182
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Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 0 and Day 182
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%.
The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
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At Day 0 and Day 182
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 182
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GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was > 2.5.
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At Day 182
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Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value
Time Frame: At Day 21
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The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
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At Day 21
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HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 21
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Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
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At Day 21
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Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value
Time Frame: At Day 182
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The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
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At Day 182
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HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain
Time Frame: At Day 182
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Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10.
The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
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At Day 182
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of any local symptom regardless of intensity grade.
Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful.
Grade 3 pain for children aged 6 to < 10 years= pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38.0
degrees Celsius (°C)].
Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination.
Grade 3 drowsiness= drowsiness that prevented normal activity.
Grade 3 irritability= crying that could not be comforted/prevented normal activity.
Grade 3 loss of appetite= not eating at all.
Grade 3 fever = fever > 39.0 °C or > 40.0 °C.
Related= general symptom assessed by the investigator as causally related to the vaccination.
This outcome measure refers to subjects aged 3 to 5 years.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above 38.0
degrees Celsius (°C)].
Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination.
Grade 3 symptom= symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C, but ≤ 40.0 °C.
Related= general symptom assessed by the investigator as causally related to the vaccination.
This outcome measure refers to subjects aged 6 to 10 years.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Medically-attended Adverse Events (MAEs)
Time Frame: Up to day 21
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
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Up to day 21
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Number of Subjects With MAEs
Time Frame: During the entire study period (Day 0 to Day 182)
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
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During the entire study period (Day 0 to Day 182)
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Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Time Frame: Up to Day 21
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Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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Up to Day 21
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Number of Subjects With pIMDs
Time Frame: During the entire study period (Day 0 to Day 182)
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Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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During the entire study period (Day 0 to Day 182)
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Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: Within the 21-day (Days 0-20) post-vaccination period
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Within the 21-day (Days 0-20) post-vaccination period
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Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: Within the 42-day (Days 0-41) post-vaccination period
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Within the 42-day (Days 0-41) post-vaccination period
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: Up to 21 days after vaccination
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Up to 21 days after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the entire study period (Day 0 to Day 182)
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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During the entire study period (Day 0 to Day 182)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2010
Primary Completion (Actual)
August 23, 2010
Study Completion (Actual)
January 31, 2011
Study Registration Dates
First Submitted
July 1, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Actual)
September 6, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Annotated Case Report Form
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 114495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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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