Nasopharyngeal Streptococcus Pneumoniae Carriage

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00471822

First received: May 8, 2007

Last updated: August 4, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2007

Last Updated Date

August 4, 2011

Start Date ^ICMJE

July 2005

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00471822 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nasopharyngeal Streptococcus Pneumoniae Carriage

Official Title ^ICMJE

An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Taiwanese Children Attending Pediatric Clinics in Hospitals, Day Care Centers, or Kindergartens

Brief Summary

Primary Objective: Evaluation of the

- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children

Secondary Objective:

Carriage rate and distribution of Streptococcus pneumoniae serotypes
Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains
Distribution of Staphylococcus aureus strain
The influence of risk factors in the Streptococcus pneumoniae carriage rate in children

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals, daycare centers, and kindergartens

Condition ^ICMJE

Streptococcus Pneumoniae Infections

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

9707

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.
Informed consent obtained from parents or legal guardian.

Exclusion Criteria:

Children younger than 2 months of age.
Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.

Gender

Both

Ages

2 Months to 5 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00471822

Other Study ID Numbers ^ICMJE

0887X-101849, B1841034

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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