Influenza A Virus Infection, Orthomyxoviridae Infections, Pandemic Influenza
Conditions
Keywords
Pandemic influenza, Avian influenza, Orthomyxoviridae Infections, A/H5N1
Brief summary
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection.
Interventions
BIOLOGICALA/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
BIOLOGICALA/H5N1 inactivated, split-virion influenza vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 18 to 40 years on 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.
Exclusion criteria
: * 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. * Previous participation in a clinical trial involving an investigational flu pandemic vaccine. * Vaccination with an influenza vaccine during the past 6 months * Any vaccination in the 4 weeks preceding the first trial vaccination * Vaccination planned in the 4 weeks following any trial vaccination * Breast-feeding. * For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination. * 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. * Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity. * Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Chronic illness at a stage that could interfere with trial conduct or completion. * Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures. * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Blood or blood-derived products received in the past 3 months. * Febrile illness (temperature ≥ 37.5°C) on the day of inclusion. * Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine | Entire study period |
Countries
Belgium
Outcome results
None listed