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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00311415 |
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
Condition | Intervention | Phase |
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Prevention of Meningococcal Infection |
Biological: Meningococcal C conjugate vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age |
Estimated Enrollment: | 252 |
Study Start Date: | October 2005 |
Ages Eligible for Study: | 2 Months to 16 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Mainz, Kehl, Neumünster, Ettenheim, Germany | |
Poland | |
Kraków, Lubartów, Lublin, Bydgosczcz, Poland |
Principal Investigator: | Novartis Vaccines - Information Services | Novartis Vaccines & Diagnostics |
Study ID Numbers: | M14P6, Impact N° 919 |
Study First Received: | April 3, 2006 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00311415 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut; Poland: Office for Registration of Medicinal Products Medical Devices and Biocides |
Prevention of Meningococcal Meningitis meningococcal vaccines conjugate |
immunology infant antibody persistence |
Bacterial Infections Antibodies Meningococcal Infections Meningitis, Meningococcal Healthy |
Meningococcal Infection Immunoglobulins Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Bacterial Infections Meningococcal Infections Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |