Healthy volunteers (Immunisation against influenza in male and female subjects 6 to 35 months of age inclusive)
Conditions
Interventions
Product Name: FLU Q-QIV
Product Code: GSK2282512A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Other descriptive name: H1N1 strain: A/California/7/2009(H1N1)pdm09-like virus
Co
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subject’s 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. •Written informed consent obtained from the parent(s)/LAR(s) of the subject. •Subjects in stable health as determined by the 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. Are the trial subjects under 18? yes Number of subjects for this age range: 601 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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 •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. •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed. •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 enrolment. •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 investiga-tor, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): A. Humoral immune response to each strain of FLU Q-QIV B. Occurrence of solicited local and general AEs;Timepoint(s) of evaluation of this end point: For A: 28 days after the last vaccine dose For B. During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days);Main Objective: •To assess the immunogenicity of FLU Q-QIV based on Center for Biologics Evaluation and Research’s (CBER)’s Seroconversion Rate (SCR) criterion for each of the four strains in children 6 to 35 months of age, approximately 28 days after completion of dosing (approximately Day 28 and Day 56 for primed and unprimed subjects, respectively). Criterion for determination of effective immunisation: The lower limit of the two-sided 95% confidence interval (CI) for SCR should be = 40% for each strain. •To describe the reactogenicity of FLU Q-QIV and Fluarix in terms of solicited local and general adverse events (AEs), during a 7-day follow-up period. ;Secondary Objective: •To test the immunogenic superiority of the B/Victoria strain present in FLU Q-QIV [in terms of GMT and SCR] in all subjects ~ 28 days after completion of dosing (~ Day 28 and Day 56 for primed and unprimed subjects, respectively) by comparing FLU Q-QIV to Fluarix. Immunogenic superiority will be concluded if: -The lower limit of the two-sided 95% CI of the GMT ratio (FLU-Q-QIV/Fluarix®) is greater than 1.5, and -The lower limit of the two-sided 95% CI for the difference in SCR (FLU-Q-QIV – Fluarix®) is greater than 10%. •To describe the immunogenicity [in terms of GMTs, SPRs, SCRs and MGIs] of FLU Q-QIV and Fluarix®. •To describe the safety of FLU Q-QIV and Fluarix® in terms of: -Unsolicited AEs during the 28-day post-vaccination follow-up period (day of vaccination and 27 subsequent days). -SAEs, MAEs, and pIMDs during the entire study period. •To evaluate the relative risk of fever of FLU Q-QIV compared to Fluarix® during a 4-day follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A. Serum anti-Haemagglutinin (HA) antibody titres against the four vaccine strains B. Occurrence of unsolicited AEs C. Occurrence of MAEs, SAEs, and pIMDs D. Occurrence of any fever or Grade 3 fever;Timepoint(s) of evaluation of this end point: For A: On Day 0 and 28 days after last vaccine dose For B: During a 28-day follow-up period (i.e., day of vaccination and 27 subsequent days) For C: During the entire study period (Day 0 to Day 180) For D: During a 4-day follow-up period after dose 1 (Day 0) or dose 2 (Day 28) | — |
Countries
Canada, Dominican Republic, Honduras
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed