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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014