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Sponsored by: |
GlaxoSmithKline |
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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: Menjugate Biological: GSK Biologicals' meningococcal vaccine GSK134612 |
Phase III |
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 |
Enrollment: | 414 |
Study Start Date: | May 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group B: Active Comparator |
Biological: Menjugate
Intramuscular administration, 1 dose
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Group A: Experimental |
Biological: GSK Biologicals' meningococcal vaccine GSK134612
Intramuscular administration, 1 dose
|
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 Investigational Site | |
Miribel, France, 01700 | |
GSK Investigational Site | |
Lingolsheim, France, 67380 | |
GSK Investigational Site | |
Vence, France, 06140 | |
GSK Investigational Site | |
Draguignan, France, 83300 | |
GSK Investigational Site | |
Saint Laurent du Var, France, 06700 | |
GSK Investigational Site | |
Vaulx en Velin, France, 69120 | |
GSK Investigational Site | |
Nice, France, 06300 | |
GSK Investigational Site | |
Paris, France, 75015 | |
GSK Investigational Site | |
Laon, France, 02000 | |
GSK Investigational Site | |
Tours, France, 37000 | |
GSK Investigational Site | |
Le Havre, France, 76600 | |
Germany | |
GSK Investigational Site | |
Berlin, Germany, 10315 | |
GSK Investigational Site | |
Berlin, Germany, 13055 | |
GSK Investigational Site | |
Berlin, Germany, 14197 | |
GSK Investigational Site | |
Berlin, Germany, 10627 | |
Germany, Baden-Wuerttemberg | |
GSK Investigational Site | |
Tettnang, Baden-Wuerttemberg, Germany, 88069 | |
Germany, Bayern | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 81241 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 81735 | |
GSK Investigational Site | |
Olching, Bayern, Germany, 82140 | |
GSK Investigational Site | |
Noerdlingen, Bayern, Germany, 86720 | |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | |
Detmold, Nordrhein-Westfalen, Germany, 32756 | |
GSK Investigational Site | |
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457 | |
GSK Investigational Site | |
Hille, Nordrhein-Westfalen, Germany, 32479 | |
GSK Investigational Site | |
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579 | |
GSK Investigational Site | |
Espelkamp, Nordrhein-Westfalen, Germany, 32339 | |
GSK Investigational Site | |
Solingen, Nordrhein-Westfalen, Germany, 42719 | |
GSK Investigational Site | |
Velbert, Nordrhein-Westfalen, Germany, 42551 | |
GSK Investigational Site | |
Goch, Nordrhein-Westfalen, Germany, 47574 | |
Germany, Rheinland-Pfalz | |
GSK Investigational Site | |
Mainz, Rheinland-Pfalz, Germany, 55131 | |
GSK Investigational Site | |
Trier, Rheinland-Pfalz, Germany, 54290 | |
GSK Investigational Site | |
Frankenthal, Rheinland-Pfalz, Germany, 67227 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111414 |
Study First Received: | May 7, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00674583 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Meningococcal vaccine Conjugate vaccine Meningococcal disease Immunogenicity Safety |
Bacterial Infections Meningococcal Infections Healthy |
Meningococcal Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |
Bacterial Infections Meningococcal Infections Gram-Negative Bacterial Infections Neisseriaceae Infections |