Safety and Local Tolerability of Prevenar in Indian Children

Wyeth

Status: Completed

Conditions: Pneumococcal Infections

Treatments: Biological: pneumococcal conjugate vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT00488800

0887X-102324

Details and patient eligibility

About

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.

Sex: All

Ages: 6 weeks to 24 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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