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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00616928 |
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
Condition | Intervention | Phase |
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Influenza |
Biological: GSK 1557484A |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years |
Estimated Enrollment: | 4440 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | September 2008 |
A Phase 3, observer-blind, placebo-controlled, multi-center study designed to evaluate the safety and immunogenicity of an investigational vaccination regimen in adults aged 18 years or older. A total of 4440 subjects are to be enrolled in the study at 35 to 50 study centers in the United States and Canada, of whom ~3330 are to receive study vaccine and ~1110 are to receive placebo. Subjects will attend formal study center visits for study assessments on Days 0, 21, 42, and 182. In addition, a telephone visit will be conducted on Day 84.
Ages Eligible for Study: | 18 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: | 110464 |
Study First Received: | January 28, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00616928 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Products and Foods Branch, Health Canada |
influenza vaccines human safety immunogenicity |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |