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Trial record 1 of 1 for:    NCT00227214
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Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.

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ClinicalTrials.gov Identifier: NCT00227214
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : June 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 27, 2005
Last Update Posted Date June 28, 2010
Study Start Date January 2004
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00227214 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 Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.
Official Title Prevalence of Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.
Brief Summary The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar. Also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children from 0 up to 14 years of age with a diagnosis of confirmed or probable pneumococcal meningitis or with a diagnosis of suspected bacterial meningitis without bacterial or viral isolation.
Condition Pneumococcal Meningitis
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
Actual Enrollment
 (submitted: June 24, 2010)
160
Original Enrollment
 (submitted: September 22, 2005)
500
Actual Study Completion Date December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00227214
Other Study ID Numbers 0887X-101539
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: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2010