At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)
In Brief
A Phase 3 clinical trial evaluating Fluarix™ and Fluzone for Influenza. Completed, enrolled 3,327 participants across 40 sites.
Detailed Summary
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.
Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.