an efficacy study of glaxosmithkline (gsk) biologicals' candidate influenza vaccine gsk2321138a in children

Conditions: Influenza

Summary: the purpose of this study is to evaluate the efficacy, immunogenicity and safety of gsk biologicals' influenza candidate vaccine gsk2321138a when compared to non-influenza vaccine comparators in children 6 to 35 months of age. recruitment will encompass at least 4 independent cohorts: a first cohort in the northern hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the northern hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in nh countries (end 2013) and subtropical countries (beginning 2014).


Eligibility criteria:
inclusion 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. * 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. exclusion criteria: * participation in a previous flu-d-qiv-004 study (115345) cohort. * 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. * 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.

Keywords: vaccine seasonal flu efficacy children