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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00545025 |
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination
Condition | Intervention | Phase |
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Influenza |
Biological: Influenza Vaccine GSK1247446A Biological: Fluarix™ |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656. |
Enrollment: | 243 |
Study Start Date: | October 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Active Comparator |
Biological: Fluarix™
Single dose, Intramuscular injection
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Group A: Experimental |
Biological: Influenza Vaccine GSK1247446A
Single dose, Intramuscular injection
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The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110674 |
Study First Received: | October 15, 2007 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00545025 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Influenza Influenza vaccine |
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 |