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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00327665 |
As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.
This protocol posting details the procedures of both the primary & extension phase.
Condition | Intervention | Phase |
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Prophylaxis Invasive Pneumococcal Diseases and Pneumonia |
Biological: 11-valent pneumococcal vaccine GSK513026 Biological: Pneumo 23™ Biological: 10-valent pneumococcal vaccine GSK513026 Biological: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study to Compare the Safety, Reactogenicity & Immunogenicity of GSK Biologicals Pneumococcal Vaccines vs the Licensed 23-Valent Pneumococcal Polysaccharide Vaccine, in Healthy Elderly Subjects |
Enrollment: | 335 |
Study Start Date: | May 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group C: Experimental |
Biological: 11-valent pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Each group receiving one of the 3 formulations
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Group D: Active Comparator |
Biological: Pneumo 23™
Single-dose intramuscular injection.
Biological: Placebo
1 intramuscular injection.
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Group E: Active Comparator |
Biological: 10-valent pneumococcal vaccine GSK513026
Two-dose intramuscular injection
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Group A: Experimental |
Biological: 11-valent pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Each group receiving one of the 3 formulations
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Group B: Experimental |
Biological: 11-valent pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Each group receiving one of the 3 formulations
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No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.
Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Ages Eligible for Study: | 65 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
GSK Investigational Site | |
Gent, Belgium, 9000 | |
Finland | |
GSK Investigational Site | |
Pirkkala, Finland, 33960 | |
Sweden | |
GSK Investigational Site | |
UPPSALA, Sweden, SE-751 85 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 106068, 106072 |
Study First Received: | May 17, 2006 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00327665 |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
pneumococcal vaccine elderly subjects Prophylaxis invasive pneumococcal diseases pneumonia |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Healthy Pneumonia |