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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00814489 |
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 3 times with an interval of respectively 2 and 4 months.
Condition | Intervention | Phase |
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Diseases Caused by Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae |
Biological: Engerix-B Biological: GSK Biologicals' investigational HIP vaccine GSK2254232A Biological: GSK Biologicals' investigational HIP vaccine GSK2254233A |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | A Study to Evaluate GSK Biologicals' Candidate Non-Typable Haemophilus Influenzae (NTHi) and S. Pneumoniae Formulation Vaccines (GSK2254232A and GSK2254233A) in Healthy Young Adults |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group C: Active Comparator |
Biological: Engerix-B
Three doses administered intramuscularly.
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Group A: Experimental |
Biological: GSK Biologicals' investigational HIP vaccine GSK2254232A
Three doses administered intramuscularly;
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Group B: Experimental |
Biological: GSK Biologicals' investigational HIP vaccine GSK2254233A
Three doses administered intramuscularly;
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Sweden | |
GSK Investigational Site | |
KARLSKRONA, Sweden, SE-371 41 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112076 |
Study First Received: | December 23, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00814489 |
Health Authority: | Sweden: Medical Products Agency |
Non-typable Haemophilus influenzae protein vaccine Streptococcus pneumoniae young adults |
Virus Diseases Haemophilus influenzae Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases |
Influenza, Human Healthy Orthomyxoviridae Infections Pneumonia |
RNA Virus Infections |