Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

Study Overview
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Brief Summary
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The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives: To describe the immune response 21 days after each vaccination. To describe the safety profiles following each vaccination.

Conditions
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Influenza, Orthomyxoviridae Infections

Intervention / Treatment
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* Biological: A/H5N1 inactivated, split-virion influenza virus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 60 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. For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after 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 (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9). 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 in the past 3 months, that might interfere with the assessment of immune response. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. Planned receipt of any vaccine in the 4 weeks following 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: A/H5N1 inactivated, split-virion influenza virus<br>* 0.5 mL, Intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine |  | Day 42 post-vaccination 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, A/H5N1 strain, Orthomyxoviridae Infections, Influenza Pandemics