Safety and Local Tolerability of Prevenar in Indian Children

NCT00488800 | Completed

• 1 other identifier: 0887X-102324
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal Infections/PC (Prevention & Control)

Interventions

pneumococcal conjugate vaccine BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: July 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: December 28, 2007

Record last verified: 2007-12