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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00316654 |
Persistence of Antibody Response to N. meningitidis Group C in Children
Condition | Intervention | Phase |
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Prevention of Meningococcal Infection |
Biological: Meningococcal C conjugate vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Multi-Center, Open-Label, Unrandomized Study to Evaluate the Persistence of Antibody Response to N. Meningitidis Group C, Before and After 2 Doses of the Conjugate Pneumococcal Vaccine, in Children Seven Months and Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine and a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule |
Estimated Enrollment: | 573 |
Study Start Date: | February 2005 |
Ages Eligible for Study: | 7 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland | |
Spain | |
Valencia, Spain |
Principal Investigator: | Novartis Vaccines - Drug Information Services | Novartis Vaccines & Diagnostics |
Study ID Numbers: | V14P38E1, Impact N° 1396 |
Study First Received: | April 19, 2006 |
Last Updated: | September 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00316654 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines; Poland: Ministry of Health |
Prevention of Meningococcal Meningitis vaccines, conjugate immunology child antibody persistence |
Bacterial Infections Antibodies Immunologic Factors Meningococcal Infections Meningitis, Meningococcal Neisseria Meningitidis |
Meningococcal Infection Immunoglobulins Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Bacterial Infections Antibodies Immunologic Factors Meningococcal Infections Physiological Effects of Drugs |
Infection Pharmacologic Actions Gram-Negative Bacterial Infections Neisseriaceae Infections |