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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00614614 |
The purpose of the study is to characterize the immunogenicity & safety study of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age (co-administered with PedvaxHIB®) or at 15-18 months of age (co-administered with Infanrix®) in primed healthy toddlers. This study is single-blinded for the primary phase and open-label for the booster phase.
Condition | Intervention | Phase |
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Invasive Neisseria Meningitidis Serogroup Diseases |
Biological: GSK vaccine 134612 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity & Safety Study of a Booster Dose of GSK's Meningococcal Vaccine 134612 Given at 12-15 Months of Age (co-Administered With PedvaxHIB®) or at 15-18 Months of Age (co-Administered With Infanrix®) in Primed Healthy Toddlers |
Estimated Enrollment: | 1176 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Weeks to 12 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110870, 110871 |
Study First Received: | January 31, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00614614 |
Health Authority: | United States: Food and Drug Administration |
Meningococcal vaccines Neisseria meningitidis Vaccines, conjugate Infants |
Toddlers Humans Immunogenicity Safety |
Neisseria meningitidis Healthy |