Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children

Verified by: Wyeth is now a wholly owned subsidiary of Pfizer, December 2007
First Received: December 21, 2007 | Last Updated: December 21, 2007 | Phase: Phase 4 | Start Date: September 2003
Overall Status: Completed | Estimated Enrollment: 101
  • …
  • Tell a FriendPrint

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...

Brief Summary

Official Title: “Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
    • plain polisacaride vaccine 23 valent to reduce carriage

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: G1
    • G1: prevenar
  • Active Comparator: G2
    • G2: pneumo 23

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: No

Secondary Measures

  • To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
    • Time Frame: 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 9 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580684

Study ID Number: 0887X-101198

ClinicalTrials.gov Identifier: NCT00580684

Health Authority: Brazil: National Committee of Ethics in Research

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00580684