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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00474526 |
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
Condition | Intervention | Phase |
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Meningitis, Meningococcal |
Biological: Meningococcal ACWY Conjugate Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants |
Estimated Enrollment: | 4500 |
Study Start Date: | March 2007 |
Ages Eligible for Study: | 2 Months to 2 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis Vaccines - Information Services | +1 800 244 7668 ext press 2 |
Study Chair: | Novartis - Vaccines | Novartis Vaccines & Diagnostics |
Responsible Party: | Novartis Vaccines ( Novartis ) |
Study ID Numbers: | V59P14 |
Study First Received: | May 16, 2007 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00474526 History of Changes |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Colombia: INVIMA |
Meningococcal meningitis vaccine |
infants Meningococcal meningitis Meningococcal disease |
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 |