An efficacy study of GlaxoSmithKline (GSK) Biologicals’ candidate influenza vaccine GSK2321138A in children
Trial overview
Number of subjects with moderate to severe RT-PCR confirmed influenza.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with RT-PCR confirmed influenza of any severity.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of lower respiratory illness (LRI) with RT-PCR confirmed influenza.
Timeframe: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to antigenically-matching influenza strains.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to antigenically-matching influenza strains
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of acute otitis media (AOM) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain.
Timeframe: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of RT-PCR confirmed severe influenza A and/or B due to any seasonal influenza strain.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against each of four vaccine strains contained in the D-QIV (in immuno subcohort of subjects only)
Timeframe: At Days 0 and 28/56
Number of seropositive subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
Timeframe: At Day 0 and Day 28/56
Number of seroconverted subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
Timeframe: At Day 28/56 (POST)
Mean geometric increase (MGI) for HI antibody titer against each of the 4 vaccine influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only).
Timeframe: At Day 28/56 (POST)
Number of seroprotected subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
Timeframe: At Day 0 and Day 28/56
Number of subjects reporting any and grade 3 solicited local symptoms.
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Number of subjects reporting any, grade 3 and related solicited general symptoms.
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Duration of solicited local symptoms
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Duration of solicited general symptoms
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 28-day (Days 0-27) post-vaccination period
Number of subjects reporting any, grade 3 and related AEs with medically attended visits (MAVs)
Timeframe: During the entire study period (approximately 6- 8 months per subject)
Number of subjects reporting any, grade 3 and related potential immune-mediated diseases (pIMDs).
Timeframe: During the entire study period (approximately 6- 8 months per subject)
Number of subjects reporting any and related serious adverse events (SAEs).
Timeframe: During the entire study period (approximately 6- 8 months per subject)
Participation criteria
- Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) 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 first vaccination; children are eligible regardless of history of influenza vaccination.
- Participation in a previous FLU-D-QIV-004 study (115345) cohort.
- Child in care.
- A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
- Written informed consent obtained from the parent(s) /LAR(s) of the subject.
- Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
- Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
- Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
- Any contraindication to intramuscular injection.
- Acute disease and/or fever at the time of enrolment.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
- Additional criteria for children ≥ 12 months of age:
- Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted. * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
- Additional criteria for children 6
- 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
- Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
Participation in a previous FLU-D-QIV-004 study (115345) cohort.
Any history of hepatitis A or varicella diseases.
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.