Influenza Clinical Trial
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.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | March 2009 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 - Breast-feeding - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
Belgium, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine | 21 Days post-vaccination | Yes |
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