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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00488800 |
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.
Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board of Health.
Condition | Intervention | Phase |
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Pneumococcal Infections |
Biological: pneumococcal conjugate vaccine |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children |
Ages Eligible for Study: | 6 Weeks to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:
For Primary Immunization Schedule:
EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.
Study ID Numbers: | 0887X-102324 |
Study First Received: | June 18, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00488800 History of Changes |
Health Authority: | India: Institutional Review Board |
Pneumococcal Infections/PC (Prevention & Control) |
Bacterial Infections Gram-Positive Bacterial Infections Streptococcal Infections Pneumococcal Infections |
Bacterial Infections Gram-Positive Bacterial Infections Streptococcal Infections Infection Pneumococcal Infections |