Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

Study Overview
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Brief Summary
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The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

Detailed Description
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This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

Official Title
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A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains)
* Biological: Fluarix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults (≥18 yrs) Stable health status Provide informed consent Access to direct phone service (NOT a pay phone or a common-use phone service) Eligible females must have a negative pregnancy test Exclusion Criteria: Febrile illness (>38.0°C oral temperature) High blood pressure (≥140/90 mmHg) Significant acute or chronic Uncontrolled medical or psychiatric illness within 1 month prior to vaccination Immunosuppressive condition (confirmed or suspected) Renal impairment Hepatic dysfunction Complicated insulin-dependent diabetes mellitus Unstable cardiopulmonary disease Blood dyscrasias Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed) History of demyelinating disease Active neurological disorder Significant alcohol or drug abuse Significant coagulation disorder (prophylactic antiplatelet medications allowed) Influenza vaccine administrated within 6 months prior to study vaccination Administration of any other vaccine from 30 days prior to the end of the study Use of non-registered drug within 30 days prior to study vaccination Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption Pregnant or nursing female subjects Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains)|nan|
|Biological: Fluarix|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 21 days after vaccination: seroconversion rate, seroprotection rate, |  |  | 
| geometric mean titer fold increase |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination; |  |  | 
| SAEs over the whole study period |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thimerosal reduced content, Immunogenicity, safety, reactogenicity, Young and elderly adults, Influenza vaccine