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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00262041 |
The purpose of this study is to evaluate the safety and immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
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, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Single-Blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of a Commercially Available Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age |
Estimated Enrollment: | 490 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 11 Years to 17 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Rochester, Minnesota, United States, 55905 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Washington | |
Seattle, Washington, United States, 98101 |
Study Director: | Novartis Vaccines | Novartis |
Study ID Numbers: | V59P6 |
Study First Received: | December 2, 2005 |
Last Updated: | September 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00262041 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Meningococcal Infections Healthy |
Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections |