Safety and Local Tolerability of Prevenar in Indian Children

NCT00488800

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-24 weeks

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Advanced Information
Descriptive Information
Brief Title Safety and Local Tolerability of Prevenar in Indian Children
Official Title A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
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.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Pneumococcal Infections
Intervention Biological: pneumococcal conjugate vaccine
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June 19, 2007)
1000
Original Enrollment Same as current
Actual Study Completion Date January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 6 Weeks to 24 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00488800
Other Study ID Numbers 0887X-102324
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007