Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

NCT ID: NCT01109108

Last Updated: 2017-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-03-31

Brief Summary

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The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children \< 5.

Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.

Detailed Description

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Conditions

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Nasopharyngeal Carriage of S. Pneumoniae

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Children <2 years of age

Children \<2 years of age with and without respiratory tract infection

No interventions assigned to this group

Children 2<5 years of age

Children 2\<5 years of age with and without respiratory tract infection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* children \< 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate

Exclusion Criteria

* children with facial malformations making NP sampling unacceptable
* children in foster care
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Stephen Pelton

Professor of Pediatrics and Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Primary Care, Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-28757

Identifier Type: -

Identifier Source: org_study_id

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