Safety and Local Tolerability of Prevenar in Indian Children

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.

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Key information

Conditions

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

Age range

6 week–24 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pneumococcal conjugate vaccine

Biological

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jun 20, 2007
Registry last updated: Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed