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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00674583 |
The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.
Condition | Intervention | Phase |
Meningococcal Disease |
Biological: GSK Biologicals' meningococcal vaccine GSK134612 Biological: Menjugate |
Phase III |
Drug Information available for: | Meningococcal Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Non-Inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children |
Estimated Enrollment: | 400 |
Study Start Date: | May 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Group A: Experimental |
Biological: GSK Biologicals' meningococcal vaccine GSK134612
Intramuscular administration, 1 dose
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Group B: Active Comparator |
Biological: Menjugate
Intramuscular administration, 1 dose
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The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for specified regions in France
France | |||||
GSK Clinical Trials Call Center | |||||
Paris, France | |||||
Germany | |||||
GSK Clinical Trials Call Center | |||||
Berlin, Germany |
GlaxoSmithKline |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 111414 |
First Received: | May 7, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00674583 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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