Clinical Trial: Safety and Local Tolerability of Prevenar in Indian Children

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children

Brief Summary:

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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: June 18, 2007
Date Started: July 2006
Date Completion:
Last Updated: December 20, 2007
Last Verified: December 2007