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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00433914 |
This study is aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
Condition | Intervention | Phase |
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Meningococcal Disease |
Biological: Serogroup B meningococcal Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Two Different Formulations of Novartis Meningococcal B Vaccine, When Administered to Healthy Infants |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2008 |
Ages Eligible for Study: | 6 Months to 8 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | V72P9, Eudract Number: 2006-005589-38 |
Study First Received: | February 9, 2007 |
Last Updated: | August 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00433914 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Meningococcal disease, prevention, vaccination |
Bacterial Infections Meningococcal Infections Healthy |
Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections |