NCT00580684

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
Last Updated

December 27, 2007

Status Verified

December 1, 2007

First QC Date

December 21, 2007

Last Update Submit

December 21, 2007

Conditions

Vaccines, PneumococcalVaccines, Pneumococcal Conjugate Vaccine

Keywords

pneumococcus conjugated vaccine 7 valent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.

    12 months

Study Arms (2)

G1

ACTIVE COMPARATOR

G1: prevenar

Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

G2

ACTIVE COMPARATOR

G2: pneumo 23

Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

Interventions

pneumococcus conjugate vaccine 7 valent to reduce carriageBIOLOGICAL

plain polisacaride vaccine 23 valent to reduce carriage

G1G2

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children between
  • to 9 years old.
  • No history of antibiotic use prior 1 month of enrollment
  • No history of invasive pneumococcal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

September 1, 2003

Study Completion

August 1, 2004

Last Updated

December 27, 2007

Record last verified: 2007-12