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

NCT ID: NCT00580684

Last Updated: 2007-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-08-31

Brief Summary

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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

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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.

Conditions

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Vaccines, Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine

Keywords

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pneumococcus conjugated vaccine 7 valent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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G1

G1: prevenar

Group Type ACTIVE_COMPARATOR

pneumococcus conjugate vaccine 7 valent to reduce carriage

Intervention Type BIOLOGICAL

plain polisacaride vaccine 23 valent to reduce carriage

G2

G2: pneumo 23

Group Type ACTIVE_COMPARATOR

pneumococcus conjugate vaccine 7 valent to reduce carriage

Intervention Type BIOLOGICAL

plain polisacaride vaccine 23 valent to reduce carriage

Interventions

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pneumococcus conjugate vaccine 7 valent to reduce carriage

plain polisacaride vaccine 23 valent to reduce carriage

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0887X-101198

Identifier Type: -

Identifier Source: org_study_id