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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00652743 |
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule.
The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number =00449670).
Condition | Intervention | Phase |
---|---|---|
Pandemic Flu |
Biological: Pandemic influenza vaccine GSK1562902A |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Vaccination Schedules |
Estimated Enrollment: | 747 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Biological: Pandemic influenza vaccine GSK1562902A
IM administration
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Ages Eligible for Study: | 19 Years to 61 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Hong Kong | |
GSK Investigational Site | |
Hong Kong, Hong Kong | |
Singapore | |
GSK Investigational Site | |
Singapore, Singapore, 308433 | |
GSK Investigational Site | |
Singapore, Singapore, 529889 | |
Taiwan | |
GSK Investigational Site | |
Taipei, Taiwan, 112 | |
Thailand | |
GSK Investigational Site | |
Bangkok, Thailand, 10700 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111443, 111470, 111471, 111472 |
Study First Received: | March 21, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00652743 |
Health Authority: | Hong Kong: Department of Health |
GSK pandemic candidate vaccine, immunogenicity, safety |
Influenza, Human |