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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

ChemIDplus related topics:   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
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 October 17, 2008




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