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Study Evaluating Prevenar in High-Risk Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234338
First Posted: October 6, 2005
Last Update Posted: December 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00234338     History of Changes
Other Study ID Numbers: 101850
First Submitted: October 4, 2005
First Posted: October 6, 2005
Last Update Posted: December 10, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs