Safety and Local Tolerability of Prevenar in Indian Children
Information source: Wyeth
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumococcal Infections
Intervention: pneumococcal conjugate vaccine (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
Study design: Prospective
Eligibility
Minimum age: 6 Weeks.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA
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
Locations and Contacts
Additional Information
Starting date: July 2006
Ending date: January 2007
Last updated: December 20, 2007
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