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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00707798 |
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.
Condition | Intervention | Phase |
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Diseases Caused by Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae |
Biological: Pneumo 23™ Biological: Pneumococcal vaccine GSK2189242A |
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 Formulations of Pneumococcal Vaccines (GSK2189242A) in Young Adults. |
Estimated Enrollment: | 156 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Formulation 5: Experimental |
Biological: Pneumococcal vaccine GSK2189242A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Formulation 2: Experimental |
Biological: Pneumococcal vaccine GSK2189242A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
|
Formulation 6: Experimental |
Biological: Pneumococcal vaccine GSK2189242A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
|
Formulation 1: Experimental |
Biological: Pneumococcal vaccine GSK2189242A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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23 valent pneumococcal vaccine: Active Comparator |
Biological: Pneumo 23™
One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
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Formulation 3: Experimental |
Biological: Pneumococcal vaccine GSK2189242A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
|
Formulation 4: Experimental |
Biological: Pneumococcal vaccine GSK2189242A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
|
This amendment was due to
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111651 |
Study First Received: | June 30, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00707798 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Streptococcus pneumoniae, Pneumococcal vaccine, Young adults |
Virus Diseases Haemophilus influenzae Respiratory Tract Diseases Respiratory Tract Infections |
Lung Diseases Influenza, Human Orthomyxoviridae Infections Pneumonia |
RNA Virus Infections |