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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00849069 |
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK2231395A candidate vaccine in adults and elderly adults with chronic obstructive pulmonary disease. Subjects will be vaccinated 3 times with an interval of respectively 2 and 10 months.
Condition | Intervention | Phase |
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Non-Typable H. Influenzae / S. Pneumoniae Infections |
Biological: TwinrixTM Biological: GSK2231395A |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | An Observer-Blind, Safety Study of GSK Biologicals' H. Influenzae and S. Pneumoniae Candidate Vaccine in Adults. |
Estimated Enrollment: | 30 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Active Comparator |
Biological: TwinrixTM
3 doses intramuscular injections
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Group A: Experimental |
Biological: GSK2231395A
3 doses intramuscular injections
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Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112350 |
Study First Received: | February 19, 2009 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00849069 History of Changes |
Health Authority: | Canada: Health Canada |
Non-typable Haemophilus influenza Streptococcus pneumoniae Adults and Elderly Adults Vaccine |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases |
Haemophilus Influenzae Influenza, Human Orthomyxoviridae Infections Pneumonia |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases |
Influenza, Human Orthomyxoviridae Infections Infection Pneumonia |