Study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ quadrivalent influenza vaccine GSK2282512A when administered to children from 6 to 35 months of age
Trial overview
Number of seroconverted subjects for Haemagglutination Inhibition (HI) antibodies against each of the four vaccine influenza strains of FluLaval® Quadrivalent vaccine.
Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
Number of seroconverted subjects for HI antibodies against each of the four vaccine influenza strains.
Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
Haemagglutination inhibition (HI) antibody titers against each of the four vaccine influenza strains
Timeframe: On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)
Number of subjects who were seroprotected for HI antibodies against each of the four vaccine influenza strains.
Timeframe: At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)
Mean geometric increase (MGI) for HI antibody titer against each of the four vaccine influenza strains.
Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
Number of subjects reporting any and grade 3 solicited local symptoms.
Timeframe: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination
Number of subjects reporting any, grade 3 and related solicited general symptoms.
Timeframe: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination
Number of subjects reporting any, grade 3 and related fever
Timeframe: During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination
Duration of solicited local and general symptoms
Timeframe: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination
Number of subjects reporting any Medically Attended Adverse Events (MAEs)
Timeframe: During the entire study period (Day 0 to Day 180)
Number of subjects reporting any potential Immune-Mediated Diseases (pIMDs)
Timeframe: During the entire study period (Day 0 to Day 180)
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).
Timeframe: During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination
Number of subjects reporting any and related serious adverse events (SAEs)
Timeframe: During the entire study period (Day 0 – Day 180)
Participation criteria
- Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
- Child in care.
- A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Subjects in stable health as determined by investigator’s clinical examination and assessment of subject’s medical history.
- Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.
Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Child in care.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
- 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.
- Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.