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Trial record 1 of 1 for:    NCT00234338
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Study Evaluating Prevenar in High-Risk Children

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.
ClinicalTrials.gov Identifier: NCT00234338
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date October 4, 2005
First Posted Date October 6, 2005
Last Update Posted Date December 10, 2007
Study Start Date October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00234338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating Prevenar in High-Risk Children
Official Title Prospective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Pneumococcal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: October¬†5,¬†2005)
5000
Original Enrollment Same as current
Actual Study Completion Date April 2007
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00234338
Other Study ID Numbers 101850
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007