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Study Evaluating Prevenar in High-Risk Children

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00234338
First received: October 4, 2005
Last updated: December 7, 2007
Last verified: December 2007
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Children
Vaccine
Prevenar

ClinicalTrials.gov processed this record on May 23, 2013