Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00772889 |
The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).
Condition | Intervention | Phase |
---|---|---|
Influenza Infection |
Biological: GSK Biologicals' Fluarix™ Biological: Influenza vaccine GSK2186877A |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly. |
Estimated Enrollment: | 1252 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group B: Active Comparator
<= 488 subjects aged >= 66 years receiving one dose of Fluarix.
|
Biological: GSK Biologicals' Fluarix™
One intramuscularly injection at Day 0
|
Group C: Active Comparator
<= 289 subjects aged 19-43 years receiving one dose of Fluarix.
|
Biological: GSK Biologicals' Fluarix™
One intramuscularly injection at Day 0
|
Group A: Experimental
<= 475 subjects aged >= 66 years receiving one dose of the GSK2186877A vaccine.
|
Biological: Influenza vaccine GSK2186877A
One intramuscularly injection at Day 0
|
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111738 |
Study First Received: | October 10, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00772889 |
Health Authority: | United States: Food and Drug Administration |
Influenza Vaccine Elderly |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections Infection |