safety and immunogenicity of an intramuscular a/h5n1 inactivated, split virion pandemic influenza vaccine in children

Conditions: Influenza; Orthomyxoviridae Infections; Orthomyxovirus Infections

Summary: this study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. study objectives: * to describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule. * to describe the immune response after each vaccination in subjects receiving study vaccine.

study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

Eligibility criteria:
inclusion criteria : all subjects * subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures. * completion of vaccination according to the national immunization schedule subjects aged ≥ 2 years to \< 18 years: * aged ≥ 2 years to \< 18 years on the day of inclusion. * provision of informed consent form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). in addition, provision of assent form signed by subjects aged 8 to 11 years, and of informed consent form signed by subjects ≥ 12 years. * for a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination. subjects aged ≥ 6 months to \< 2 years: * aged ≥ 6 months to \< 2 years on the day of inclusion. * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. * provision of informed consent form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations). exclusion criteria : all subjects * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination * planned participation in another clinical trial during the present trial period * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances * chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response * receipt of any vaccine in the 4 weeks preceding trial vaccination * planned receipt of any vaccine in the 4 weeks following any trial vaccination * (known) human immunodeficiency virus (hiv), hepatitis b surface (hbs) antigen or hepatitis c seropositivity * previous vaccination against avian influenza with either the trial vaccine or another vaccine * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating im vaccination * subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * received oral or injected antibiotic therapy within the 72 hours prior to any blood draw subjects aged ≥2 years to \<18 years: * for a female of child-bearing potential, known pregnancy or positive urine pregnancy test * breast-feeding female * febrile illness (temperature ≥ 37.5 °c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment subjects aged ≥ 6 months to \< 2 years: * history of seizures * febrile illness (temperature ≥ 38 °c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Keywords: influenza orthomyxoviruses split virion pandemic influenza vaccine a/h5n1