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Fluarix Immunogenicity and Safety Trial

Influenza Clinical Trial

Official title:
A Randomized, Double-blinded, Placebo Controlled Phase III Study to Evaluate the Immunogenicity and Safety of GSK Bio Influenza Vaccine (Fluarix) Administered Intramuscularly in Healthy Adults

Clinical Trial Summary

The purpose of this study is to test the immune response caused by investigational Fluarix vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4 centers will receive Fluarix or Placebo (saline), and their responses will then be compared. Subjects will be placed by age into 2 groups (18 to 49 years old and 50 to 64 years old), then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle. There will be 2 phases in this study: (1) the active study phase (2 visits) for all subjects; and (2) the cross-over phase, only for subjects enrolled in the placebo group who accept to receive Fluarix. Blood samples will be obtained in order to measure immune response to the vaccine. On the day of vaccination, volunteers will receive a diary card to record information on symptoms experienced during the next 3 days. Subject participation in either group will be up to 2 months.

Clinical Trial Description

This study is a randomized, double-blinded, placebo controlled Phase III study to evaluate the immunogenicity and the safety of GSK Bio influenza vaccine (Fluarix) administered intramuscularly in healthy adults aged 18 to 64 years. Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. Following vaccination, seroprotective antibody titers are achieved in a high proportion of vaccinated subjects. GlaxoSmithKline Biologicals (GSK Bio) has been marketing an inactivated influenza split vaccine (Fluarix®) since 1992. More than 126 million doses have been distributed and the vaccine is registered in 78 countries. It has been well tolerated and has proven to be highly immunogenic when injected by the intramuscular route. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00100399
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 3
Start date December 2004
Completion date December 2004
View Details
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