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NCT00234338 Clinical Trial

Study Evaluating Prevenar in High-Risk Children

Pneumococcal Disease Clinical Trial

Official title:
Prospective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00234338
Other study ID # 101850
Secondary ID
Status Completed
Phase N/A
First received October 4, 2005
Last updated December 7, 2007
Start date October 2005
Est. completion date April 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 5000
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 5 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

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