Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Study Overview
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Brief Summary
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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.

Conditions
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Pandemic Influenza, Influenza A Virus Infection, Orthomyxoviridae Infections

Intervention / Treatment
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* Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
* Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
* Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
* Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
* Biological: A/H5N1 inactivated, split-virion influenza vaccine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Dose 1 with Adjuvant | Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Group 2<br>Dose 2 with adjuvant | Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Group 3<br>Dose 3 with adjuvant | Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Group 4<br>Dose 4 with adjuvant | Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant<br>* 0.5 mL, Intramuscular<br>|
| Active Comparator: Group 5<br>Control | Biological: A/H5N1 inactivated, split-virion influenza vaccine<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 safety of A/H5N1 Inactivated split influenza virus vaccine |  | Entire study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pandemic influenza, Avian influenza, Orthomyxoviridae Infections, A/H5N1