Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Fluarix (Biological); Fluzone (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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)
Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety and immunological non-inferiority (GMT and seroconversion rates) of Fluarix versus Fluzone
Secondary outcome: Immunogenicity comparison (Fluarix vs Fluzone) in terms of seroconversion, seroprotection & GMTsReactogenicity: Solicited local & general symptoms Unsolicited adverse events Serious adverse events
Eligibility
Minimum age: 6 Months.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All children with consent.
Exclusion Criteria:
- No non-study investigational vaccines or drugs.
- No hypersensitivities to vaccine or its components.
- No pregnancies.
Locations and Contacts
GSK Clinical Trials Call Center, San Francisco, California 94102, United States
GSK Clinical Trials Call Center, Englewood, Colorado 80112, United States
GSK Clinical Trials Call Center, Tifton, Georgia 31794, United States
GSK Clinical Trials Call Center, Bardstown, Kentucky 40004, United States
GSK Clinical Trials Call Center, Metairie, Louisiana 70006, United States
GSK Clinical Trials Call Center, Whitehouse Station, New Jersey 08889, United States
GSK Clinical Trials Call Center, Rochester, New York 14609, United States
GSK Clinical Trials Call Center, Cary, North Carolina 27518, United States
GSK Clinical Trials Call Center, Uniontown, Pennsylvania 15401, United States
GSK Clinical Trials Call Center, Austin, Texas 78728, United States
GSK Clinical Trials Call Center, West Jordan, Utah 84084, United States
Additional Information
Starting date: October 2006
Ending date: October 2007
Last updated: January 25, 2008
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