NCT00724828

Brief Summary

Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

Enrollment Period

6 months

First QC Date

July 25, 2008

Last Update Submit

July 29, 2008

Conditions

Pneumonia, Bacterial

Keywords

Bacterial otitis mediapneumoniaesepsisbacteremiameningitisStreptococcus pneumoniae carriage rate

Outcome Measures

Primary Outcomes (1)

  • Streptococcus pneumoniae serotype carriage rate based on a nasopharyngeal swab.

    1 day

Study Arms (1)

1

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital.
  • Informed consent obtained from parents or legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, BacterialSepsisBacteremiaMeningitis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroinflammatory DiseasesNervous System Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 30, 2008

Study Start

May 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

July 30, 2008

Record last verified: 2008-07