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Study Evaluating Prevenar in High-Risk Children
This study has been completed.
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00234338
  Purpose

The purpose of this study is to estimate the local and systemic tolerability of Prevenar in children ages 2 to 5 years old in usual care settings.


Condition
Pneumococcal Disease

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Prospective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years

Further study details as provided by Wyeth:

Estimated Enrollment: 5000
Study Start Date: October 2005
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High-risk children ages 2 to 5 years old

Exclusion criteria:

  • Prior administration of Prevenar
  • Prior and/or concurrent administration of 23 vPs vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234338

Locations
Germany
Frankfurt, Germany, 60590
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
  More Information

Study ID Numbers: 101850
Study First Received: October 4, 2005
Last Updated: December 7, 2007
ClinicalTrials.gov Identifier: NCT00234338  
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Wyeth:
Children
Vaccine
Prevenar

ClinicalTrials.gov processed this record on January 16, 2009



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