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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00310635 |
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Condition | Intervention | Phase |
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Meningococcal Infection |
Biological: Meningococcal C conjugate vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age |
Estimated Enrollment: | 241 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 32 Months to 40 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Kempten | |
Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer, | |
Oppenheim,, Kempten, Germany |
Principal Investigator: | Vaccines - Information Services | Novartis Vaccines & Diagnostics |
Study ID Numbers: | M14P1E1, Impact N° 1453 |
Study First Received: | April 3, 2006 |
Last Updated: | October 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00310635 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Prevention of meningococcal infection |
Bacterial Infections Meningococcal Infections Meningococcal Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |
Bacterial Infections Meningococcal Infections Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |