Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
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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.
Condition or disease
Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains)Biological: Fluarix
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.
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.
Study Start Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)
Complicated insulin-dependent diabetes mellitus
Unstable cardiopulmonary disease
Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)