trial to evaluate the safety and the immunogenicity of gsk biologicals' influenza vaccine gsk2186877a in healthy children

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety and immunogenicity of glaxosmithkline biologicals' influenza vaccine gsk2186877a in healthy children 6 to 35 months of age. this protocol posting has been updated following amendment 1 of the protocol, jun 2010. the impacted sections are study design, outcome measures, intervention sections and number of subjects.


Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * children, 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. * healthy subjects as established by medical history and clinical examination before entering into the study. * age appropriate scheduled childhood vaccinations completed to the best of parent(s)/lar(s) knowledge. exclusion criteria: the following criteria should be checked at the time of study entry. if any exclusion criterion applies, the subject must not be included in the study: * child in care * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * prior receipt of any influenza vaccination (seasonal or pandemic) or planned administration during the study period. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * 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 prednisone \>0.5 mg/kg of body weight, or equivalent. inhaled and topical steroids are allowed. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * a family history of congenital or hereditary immunodeficiency. * any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to consumption of egg proteins. * history of any neurological disorders or seizures (including febrile convulsion). * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination. * acute disease and/or fever at the time of enrolment: * fever is defined as temperature \>= 37.5°c on oral, axillary or tympanic setting, or \>=38.0°c on rectal setting. * subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever might be enrolled at the discretion of the investigator. * administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period. * any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.

Keywords: children influenza safety immunogenicity vaccine