At a glance
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Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals' Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 Years &Amp; Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 Years)
In Brief
A Phase 2 clinical trial evaluating Fluarix, Fluarix-AS25, and 3 other interventions for Influenza. Completed, enrolled 425 participants across 1 site.
Detailed Summary
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
Study Details
Timeline
Interventions
1 dose administered intramuscularly in the deltoid region of the non-dominant arm
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
1 dose administered intramuscularly into the deltoid region of the non-dominant arm