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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00329849 |
Safety and immunogenicity of Meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age
Condition | Intervention | Phase |
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Meningococcal Disease |
Biological: Meningococcal ACWY conjugate vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Observer Blind Multi-Center Study to Compare the Safety of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age |
Estimated Enrollment: | 1500 |
Study Start Date: | May 2006 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Argentina | |
Centro di Desarrollo de Projectos Avanzados (CEDEPAP) Roma 1465 | |
Cordoba, Argentina | |
FUNCEI, French 3085 | |
Buenos Aires, Argentina | |
Hospital de Pediatria "Sor Maria Ludovica", Calle 14, N°1632 | |
La Plata, Argentina |
Study Chair: | Novartis Vaccines - Drug Information Services | Novartis Vaccines & Diagnostics |
Study ID Numbers: | V59P10 |
Study First Received: | May 23, 2006 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00329849 |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Meningitis children vaccine safety efficacy |
Bacterial Infections Meningococcal Infections Healthy Meningococcal infection |
Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |