Safety and Local Tolerability of Prevenar in Indian Children

Pneumococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488800
• Other study ID #: 0887X-102324
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: December 20, 2007
• Start date: July 2006
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 24 Months

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• pneumococcal conjugate vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer