NCT00488371

Brief Summary

Primary Objective: To evaluate the impact of PCV7 vaccination on NP carriage rate of vaccine serotypes and serotype distribution Secondary Objective: To evaluate the impact of PCV7 vaccination on NP carriage of antibiotic resistant pneumococci and serotype distribution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
Last Updated

December 20, 2007

Status Verified

December 1, 2007

First QC Date

June 18, 2007

Last Update Submit

December 16, 2007

Conditions

Pneumococcal Infections

Keywords

Streptococcus pneumoniae nasopharyngeal carriage

Interventions

Pneumococcal Conjugated Vaccine (Prevnar®)BIOLOGICAL

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged 2 to 5 years old identified by the Taipei City government and are participating in Taipei City's PCV7 vaccination program.
  • Informed consent obtained from parents or legal guardian.
  • Eligible to receive 1 dose of PCV7

You may not qualify if:

  • Children with any of the following conditions: immunologic diseases; neoplastic disorders; renal, cardiac, hepatic, or hematologic diseases; bronchodysplasia; Down syndrome; chronic otitis media with effusion.
  • Children with any acute illness including mild acute respiratory infection or fever \> 38 centigrade.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Taiwan, medinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

November 1, 2006

Study Completion

April 1, 2007

Last Updated

December 20, 2007

Record last verified: 2007-12