An efficacy study of GSK Biologicals’ quadrivalent influenza vaccine GSK2321138A in childre

• Conditions: Healthy volunteers (Immunization against influenza A and/or B in children aged 6 months to 35 months).; MedDRA version: 17.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-000758-41-CZ
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-18
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12000

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified