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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00262002 |
The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Chiron Meningococcal ACWY Conjugate Vaccine administered to healthy infants.
Condition | Intervention | Phase |
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Prevention of Meningococcal Disease |
Biological: Meningococcal Conjugate ACWY Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age |
Estimated Enrollment: | 600 |
Study Start Date: | September 2004 |
Ages Eligible for Study: | 55 Days to 89 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, British Columbia | |
Vancouver, British Columbia, Canada | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada | |
United Kingdom | |
Oxford, United Kingdom |
Study Director: | Novartis Vaccines | Novartis Vaccines & Diagnostics |
Study ID Numbers: | V59P5, 2004-000195-13 |
Study First Received: | December 2, 2005 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00262002 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada |
Bacterial Infections Meningococcal Infections Healthy |
Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections |