Safety and Local Tolerability of Prevenar in Indian Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumococcal Infections

Keywords

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Pneumococcal Infections/PC (Prevention & Control)

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0887X-102324

Identifier Type: -

Identifier Source: org_study_id