Study Evaluating the Nasopharyngeal Carriage in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00768833
First received: October 7, 2008
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition
Healthy Subjects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number and frequency of S. pneumonia positive serotypes [ Time Frame: 57 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in number and frequency of S. pneumonia positive children at different ages over time [ Time Frame: 57 month ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: October 2008
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768833

Locations
Germany
Pfizer Investigational Site
Offenbach, Germany, 63069
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00768833     History of Changes
Other Study ID Numbers: 0887X1-4453
Study First Received: October 7, 2008
Last Updated: August 20, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Pfizer:
S.pneumoniae healthy subjects
Healthy subjects

ClinicalTrials.gov processed this record on August 28, 2014