Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
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Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria :
Aged over 18 years on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures
For a woman, inability to bear a child or negative urine pregnancy test
For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.
Exclusion Criteria :
Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion
Previous vaccination with an avian flu vaccine
Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
Receipt of blood or blood-derived products within the past 3 months
Any vaccination within 4 weeks prior to the first trial vaccination
Vaccination planned within 4 weeks after any trial vaccination
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.