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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00580684
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Vaccines, Pneumococcal
Vaccines, Pneumococcal Conjugate Vaccine
Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: September 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Active Comparator: G1
G1: prevenar
Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
plain polisacaride vaccine 23 valent to reduce carriage
Active Comparator: G2
G2: pneumo 23
Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
plain polisacaride vaccine 23 valent to reduce 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.

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580684

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00580684     History of Changes
Other Study ID Numbers: 0887X-101198
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
pneumococcus conjugated vaccine 7 valent

ClinicalTrials.gov processed this record on April 22, 2014