safety and immunogenicity of 2 formulations of an intramuscular a/h5n1 pandemic influenza vaccine in children

Conditions: Influenza; Orthomyxoviridae Infections; Influenza A Virus Infection

Summary: this is an open, randomized, multicenter clinical trial. objectives: * to describe the safety profiles during the 21 days following each primary and booster injection. * to describe the immune response 21 days after each primary and booster injection of each formulation. * to describe the antibody persistence after the first vaccination


Eligibility criteria:
inclusion criteria : all subjects: * able to attend all scheduled visits and to comply with all trial procedures. children/adolescents aged ≥ 2 years to \< 18 years: * aged ≥ 2 years to \< 18 years on the day of inclusion. * informed consent form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate. * for a female, inability to bear a child or negative urine pregnancy test (as applicable). * for a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable). infants/toddlers 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 kg. * informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate. * subject who completed vaccination according to the national immunization schedule. exclusion criteria : all subjects: * participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * planned participation in another clinical trial during the present trial period. * congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy. * systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9). * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the past 3 months. * any vaccination in the 4 weeks preceding the first trial vaccination. * vaccination planned in the 4 weeks following any trial vaccination. * history of the h5n1 infection (confirmed either clinically, serologically or virologically). * known hiv, hepatitis b (hbsag) or hepatitis c seropositivity. * previous vaccination with an avian flu vaccine. * subject at high risk of the h5n1 infection during the trial. * thrombocytopenia or bleeding disorder contraindicating im vaccination. * febrile illness (rectal equivalent temperature ≥ 38.0°c) on the day of inclusion. children/adolescents aged ≥ 2 years to \< 18 years: * breast-feeding mothers. * current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures (if applicable, depending on the subject's age). infants/toddlers aged ≥ 6 months to \< 2 years: * history of seizures.

Keywords: influenza a/h5n1 virus influenza pandemic orthomyxoviridae infections