Safety and Local Tolerability of Prevenar in Indian Children
|ClinicalTrials.gov Identifier: NCT00488800|
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : December 28, 2007
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 or disease||Intervention/treatment||Phase|
|Pneumococcal Infections||Biological: pneumococcal conjugate vaccine||Phase 4|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children|
|Study Start Date :||July 2006|
|Primary Completion Date :||January 2007|
|Study Completion Date :||January 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488800
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|