Healthy volunteers (Immunization against influenza A and/or B in children aged 6 months to 35 months). MedDRA version: 17.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Influsplit Tetra/Fluarix Tetra
Product Name: quadrivalent seasonal influenza vaccine (Flu D-QIV)
Product Code: GSK2321138A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that their parents/ LAR(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, reporting an ILI or MAV using internet access, being available for follow-up phone contacts). • 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 Are the trial subjects under 18? yes Number of subjects for this age range: 12000 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Participation in a previous FLU-D-QIV-004 study (115345) cohort. • Child in care • Use of any investigational or non-registered product (drug or vaccine) 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 (registered or investigational) 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 (no laboratory testing required). • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean a dose equivalent to either >= 0.5 mg/kg of body weight or maximum of 10 mg/day of prednisone or equivalent. 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 (including egg proteins), non-influenza vaccine comparators (including neomycin) 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. Fever is defined as temperature =37.5°C by any route. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. • 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. • Any history of hepatitis A or varicella diseases. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of FLU D-QIV in the prevention of RT-PCR confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain, when compared to non-influenza vaccine controls in children aged 6 to 35 months. • To evaluate the efficacy of FLU D-QIV in the prevention of RT-PCR confirmed influenza A and/or B disease due to any seasonal influenza strain, when compared to non-influenza vaccine controls in children aged 6 to 35 months. ;Secondary Objective: -To evaluate the efficacy of FLU D-QIV when compared to non-influenza vaccine controls in the prevention of: • lower respiratory illness (LRI) and acute otitis media (AOM) associated with RT-PCR confirmed influenza A and/or B (at any time starting 7 days before the onset of LRI and ending 7 days after end of LRI) • culture confirmed moderate to severe and of any severity influenza A and/or B disease due to antigenically-matching influenza strains and any seasonal influenza strain. • RT-PCR confirmed severe influenza A and/or B disease. -To evaluate the immunogenicity of FLU D-QIV in terms of HI antibody response 28 days after completion of vaccination, in an immuno sub-cohort of subjects -To evaluate the reactogenicity of FLU D-QIV and non-influenza vaccine controls in terms of: • solicited local and general adverse events (AEs) and unsolicited symptoms during 7 days and 28 days respectively after each vaccination • AEs with MAV, SAEs and pIMDs during the entire study period;Primary end point(s): • First occurrence of RT-PCR confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain • First occurrence of RT-PCR confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain ;Timepoint(s) of evaluation of this end point: during the surveillance period (approximately 6 to 8 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • First occurrence of Lower respiratory illness (LRI) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain identified at any time starting 7 days before the onset of LRI and ending 7 days after end of LRI • First occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to antigenically-matching influenza strains. • First occurrence of culture-confirmed influenza A and/or B disease of any severity due to antigenically-matching influenza strains. • First occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain. • First occurrence of culture-confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain. • First occurrence of acute otitis media (AOM) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain identified at any time starting 7 days before the onset of AOM and ending 7 days after end of AOM • First occurrence of RT-PCR confirmed severe influenza A and/or B due to any seasonal influenza strain. Immunogenicity: • Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against each of four vaccine strains contained in FLU D-QIV (in immuno sub-cohort of subjects only). Derived variables: - Geometric Mean Titres (GMTs) of HI antibody titres - Seropositivity rates - Seroconversion rates (SCR)* - Mean geometric increase (MGI) ** - Seroprotection rates (SPR) *** *SCR is defined as the percentage of vaccinees that have either a pre-vaccination titre < 1:10 and a post-vaccination titre =1:40 or a pre-vaccination titre =1:10 and at least a four-fold increase in post-vaccination titre. **MGI is defined as the fold increase in serum HI GMTs post-vaccination compared to prevaccination. ***SPR is defined as the percentage of vaccinees with a serum HI titre =1:40 that usually is accepted as | — |
Countries
Bangladesh, Belgium, Czech Republic, Dominican Republic, Honduras, India, Lebanon, Philippines, Poland, Spain, Thailand, Turkey, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed