Study to evaluate the safety and immunogenicity of GSK Biological pandemic candidate influenza vaccine (H1N1) in children
Trial overview
Haemagglutination inhibition (HI) antibody titers against vaccine H1N1 antigen
Timeframe: At Day 42
Number of seropositive subjects for HI antibodies
Timeframe: At Day 42
Number of seroconverted subjects in terms of HI antibodies
Timeframe: At Day 42
Number of seroprotected subjects for HI antibodies
Timeframe: At Day 42
Geometric mean fold increase (GMFR) for serum HI antibody titer
Timeframe: At Day 42
Number of seropositive subjects for HI antibodies
Timeframe: At Day 0, Day 21 and Month 7
HI antibody titers against vaccine H1N1 antigen
Timeframe: At Day 0, Day 21 and Month 7
Number of seroconverted subjects in terms of HI antibodies
Timeframe: At Day 21 and Month 7
Number of seroprotected subjects for HI antibodies
Timeframe: At Day 0, Day 21 and Month 7
Geometric mean fold increase (GMFR) for serum HI antibody titer
Timeframe: At Day 21 and Month 7
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any medically-attended events (MAEs)
Timeframe: During the entire study period (from Month 0 up to Month 12)
Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)
Timeframe: During the entire study period (from Month 0 up to Month 12)
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within the 42-day (Days 0-41) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 to Month 12)
Participation criteria
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- Healthy children, as established by medical history and clinical examination when entering the study.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Have received any seasonal flu vaccine since last year.
- Previous administration of any H1N1 A/California-like vaccine
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment:
- Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- Child in Care.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) 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.