a study to evaluate the safety and immunogenicity of a prime-boost schedule of gsk biologicals' influenza vaccine in children

Conditions: Influenza

Summary: the purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of gsk biologicals' influenza vaccine in children aged 3 to 17 years.

in this study influenza vaccine gsk1562902a is the primary study vaccine and havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.therefore, there exist no relation between the vaccines administered in this study. as the study will be carried out in philippines, havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.

Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * subjects for whom the investigator believes that the parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol . * a male or female child 3 to 17 years of age inclusive, at the time of the first vaccination. * written informed consent obtained from the subject's parent or guardian. assent obtained from the subject when applicable. * good general health as established by medical history and clinical examination before entering into the study. * comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits. * parent/lar with access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments). * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. 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 other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration. * active participation in other clinical trials. * receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. topical, intra-articular or inhaled glucocorticoids are allowed. * acute disease and/or fever at the time of enrolment: * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * an acute evolving neurological disorder or history of guillain-barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. * receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period. * any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine. * history of seizures or progressive neurological disease. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions. * diagnosed with cancer or any chronic severe disease. * previous administration of any h5n1 vaccine.

Keywords: influenza h5n1 vaccine children