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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00310856 |
To assess the immunogenicity of Chiron Men ACWY conjugate vaccine (Men ACWY) when administered as a two-dose schedule at 6 and 12 months of age.
Condition | Intervention | Phase |
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Meningococcal Meningitis |
Biological: Meningococcal ACWY conjugate vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of a Commercially Available Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children |
Estimated Enrollment: | 175 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 6 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Clinical Trials Research Center, Department of Pediatrics, Dalhousie University IWK Health Center | |
Halifax, Canada, B3K 6R8 | |
Children's Hospital of Eastern Ontario Research Institute | |
Ottawa, Canada | |
Canada, Ontario | |
Herridge Community Health Clinic | |
Ottawa, Ontario, Canada |
Principal Investigator: | Novartis Vaccines - Drug Information Services | Novartis Vaccines & Diagnostics |
Study ID Numbers: | V59P9 |
Study First Received: | April 3, 2006 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00310856 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
meningitis children vaccine |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Meningitis, Bacterial Meningitis, Meningococcal Central Nervous System Diseases |
Meningococcal Infection Healthy Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Meningitis, Bacterial Nervous System Diseases Central Nervous System Bacterial Infections |
Meningitis, Meningococcal Central Nervous System Diseases Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |