NCT00768833

Brief Summary

The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

5.8 years

First QC Date

October 7, 2008

Last Update Submit

August 20, 2014

Conditions

Healthy Subjects

Keywords

S.pneumoniae healthy subjectsHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Number and frequency of S. pneumonia positive serotypes

    57 months

Secondary Outcomes (1)

  • Changes in number and frequency of S. pneumonia positive children at different ages over time

    57 month

Eligibility Criteria

Age3 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Age at enrolment 3 to 4 month Main

You may not qualify if:

  • Malformation or injury of the nasopharynx
  • Known or suspected immunodeficiency
  • Relevant immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Offenbach, 63069, Germany

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

DE(1)