NCT00380211CompletedPhase 3
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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 660
- Locations
- 6
- Primary Endpoint
- geometric mean titer fold increase
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
geometric mean titer fold increase
21 days after vaccination: seroconversion rate, seroprotection rate,
Secondary Outcomes
- Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
- SAEs over the whole study period
Investigators
Study Sites (6)
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