Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Official Title
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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects

Conditions
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Influenza

Intervention / Treatment
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* Biological: non-elderly aged between 18 and 60
* Biological: elderly aged over 60


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or non-pregnant females and aged ≥ 18 years; Willing and able to adhere to visit schedules and all study requirements; Subjects read and signed the study-specific informed consent. Exclusion Criteria: Subject or his/her family is employed by the participated hospital; Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months; History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication Personal or family history of Guillain-Barré Syndrome An acute febrile illness within 1 week prior to vaccination; Current upper respiratory illness, including the common cold or nasal congestion within 72 hours Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough Female subjects who are pregnant during the study Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent Immunodeficiency, or under immunosuppressive treatment Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples); Receipt of any blood products, including immunoglobulin in the prior 3 months; Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AdimFlu-S 2011-2012<br> | Biological: non-elderly aged between 18 and 60<br>* one dose of 0.5mL AdimFlu-S<br>Biological: elderly aged over 60<br>* one dose of 0.5mL AdimFlu-S<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40. | Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI). | 3 weeks post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccine, immunogenicity