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Safety and Local Tolerability of Prevenar in Indian Children

NCT00488800 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2007-12-28

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

pneumococcal conjugate vaccine

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility

Min Age
6 Weeks
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-01-31
Completion
2007-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488800 on ClinicalTrials.gov