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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00742885 |
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.
Condition | Intervention | Phase |
Pandemic Influenza |
Biological: (Pre-) pandemic influenza vaccine GSK1557484A |
Phase II |
MedlinePlus related topics: | Flu |
Drug Information available for: | Influenza Vaccines Fluvirin |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1557484A. |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
H5N1 Group: Experimental |
Biological: (Pre-) pandemic influenza vaccine GSK1557484A
Two IM injections
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Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111756 |
First Received: | August 27, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00742885 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
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