Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Study Overview
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Brief Summary
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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.

Conditions
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Influenza, Orthomyxoviridae Infections

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group 1<br>Vaccine with adjuvant | Biological: A/H5N1 inactivated, split-virion influenza virus<br>* 0.5mL, Intramuscular<br>|
| Experimental: Study Group 2<br>Vaccine without adjuvant | Biological: A/H5N1 inactivated, split-virion influenza virus<br>* 0.5mL, 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 an A/H5N1 inactivated, split-virion influenza virus vaccine |  | 21 Days post-vaccination | 

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