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

December 21, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

101

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 21, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0887X-101198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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