Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

Study Overview
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Brief Summary
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This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP) Objectives: To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96. To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.

Official Title
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Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Conditions
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Influenza, Orthomyxoviridae Infections

Intervention / Treatment
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* Biological: Split virion, inactivated Influenza vaccine
* Biological: Split virion, inactivated Influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged 18 to 60 years or 61 years and older on the day of inclusion Provision of a signed informed consent Able to attend all scheduled visits and comply with all trial procedures For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 21 days after vaccination Exclusion Criteria : For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at visit 01 Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Current alcohol abuse or drug addiction 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 trial vaccination Planned receipt of any vaccine in the 3 weeks following the trial vaccination Previous vaccination against influenza in the previous 6 months Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Age 16 to 60 years | Biological: Split virion, inactivated Influenza vaccine<br>* 0.5 mL, Intramuscular (IM)<br>|
| Experimental: Group 2<br>Age over 60 years | Biological: Split virion, inactivated Influenza vaccine<br>* 0.5 mL, Intramuscular (IM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated). |  | 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, Orthomyxoviruses, Split-virion influenza vaccine