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

Phase 4

Completed

• Conditions: Vaccines, Pneumococcal; Vaccines, Pneumococcal Conjugate Vaccine
• Interventions: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

• Registration Number: NCT00580684
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Timeline

• Study Start: 2003-09
• Study Completion: 2004-08
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Last Update Submitted: 2007-12-21
• Study First Posted: 2007-12-27
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G1	pneumococcus conjugate vaccine 7 valent to reduce carriage	G1: prevenar
G2	pneumococcus conjugate vaccine 7 valent to reduce carriage	G2: pneumo 23

Primary Outcome Measures

Name	Time	Method
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.	12 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.	12 months