Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

Study Overview
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Brief Summary
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To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Official Title
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A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects

Conditions
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Influenza

Intervention / Treatment
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* Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 65 years of age or older Exclusion Criteria: any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days fever within the past 3 days

Ages Eligible for Study
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Minimum Age: 65 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: Arm 1<br> | Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008<br>* A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens: A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain) A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain) B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season. The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes. A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96) | The measures of immunogenicity for each antigen are: the geometric mean area (GMA) on Day 0 and Day 21 the Day 21/Day 0 geometric mean area ratio (GMR) the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21 Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. Significant increase in antibody titer is defined as at least a 50% increase in area. | 21 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years). | Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). | 3 days, respectively 21 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvanted Influenza Vaccine