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NCT00768833 Clinical Trial

Study Evaluating the Nasopharyngeal Carriage in Healthy Children

Healthy Subjects Clinical Trial

— Carriage  

Official title:
Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00768833
Other study ID # 0887X1-4453
Secondary ID
Status Completed
Phase N/A
First received October 7, 2008
Last updated August 20, 2014
Start date October 2008
Est. completion date August 2014

Study information
Verified date August 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 242
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 4 Months
Eligibility Inclusion Criteria:

Main inclusion criteria:

- Age at enrolment 3 to 4 month Main

Exclusion Criteria:

- Malformation or injury of the nasopharynx

- Known or suspected immunodeficiency

- Relevant immunosuppression

- Use of antibiotics up to 10 days prior to study inclusion

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Pfizer Investigational Site Offenbach

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and frequency of S. pneumonia positive serotypes 57 months No
Secondary Changes in number and frequency of S. pneumonia positive children at different ages over time 57 month No
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