Influenza, Orthomyxoviridae Infections
Conditions
Keywords
Influenza, Orthomyxoviridae Infections, Influenza Pandemics, A/H5N1 strain
Brief summary
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.
Interventions
0.5mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine | 21 Days post-vaccination |
Countries
Belgium, United Kingdom
Outcome results
None listed