Safety and Local Tolerability of Prevenar in Indian Children - Full Text View

Purpose

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	Intervention	Phase
Pneumococcal Infections	Biological: pneumococcal conjugate vaccine	Phase IV

ChemIDplus related topics:

Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

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

Further study details as provided by Wyeth:

Estimated Enrollment:	1000
Study Start Date:	July 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Weeks to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488800

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Study ID Numbers:	0887X-102324
First Received:	June 18, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00488800
Health Authority:	India: Institutional Review Board

Keywords provided by Wyeth:

Pneumococcal Infections/PC (Prevention & Control)

Study placed in the following topic categories:

Bacterial Infections

Gram-Positive Bacterial Infections

Streptococcal Infections

Pneumococcal Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00488800