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Safety and Local Tolerability of Prevenar in Indian Children

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ClinicalTrials.gov Identifier: NCT00488800
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : December 28, 2007
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: pneumococcal conjugate vaccine Phase 4

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:

For Primary Immunization Schedule:

  • Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
  • For Catch-up Immunization Schedule:
  • Healthy male or female subjects 12-23 months of age

EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.

  • A known or suspected history of Streptococcus pneumoniae disease.
  • A previous anaphylactic or other severe vaccine-associated adverse event.
  • A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents.
  • A major congenital, developmental or serious chronic disorder.
  • A confirmed or suspected underlying evolving neurological disorder or history of seizures.
  • A history of thrombocytopenia or any coagulation disorder.
  • Any acute illness at the time of vaccine administration
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488800

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00488800     History of Changes
Other Study ID Numbers: 0887X-102324
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Pneumococcal Infections/PC (Prevention & Control)

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs