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Trial record 1 of 1 for:    NCT00580684
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Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children

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ClinicalTrials.gov Identifier: NCT00580684
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : December 27, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE December 27, 2007
Last Update Posted Date December 27, 2007
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage. [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
Official Title  ICMJE Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.
Brief Summary To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
Detailed Description This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Vaccines, Pneumococcal
  • Vaccines, Pneumococcal Conjugate Vaccine
Intervention  ICMJE Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
plain polisacaride vaccine 23 valent to reduce carriage
Study Arms  ICMJE
  • Active Comparator: G1
    G1: prevenar
    Intervention: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
  • Active Comparator: G2
    G2: pneumo 23
    Intervention: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
101
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy children between
  • 2 to 9 years old.
  • No history of antibiotic use prior 1 month of enrollment
  • No history of invasive pneumococcal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580684
Other Study ID Numbers  ICMJE 0887X-101198
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP