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Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109108
First Posted: April 22, 2010
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stephen Pelton, Boston Medical Center
  Purpose

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.


Condition
Nasopharyngeal Carriage of S. Pneumoniae

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci

Resource links provided by NLM:


Further study details as provided by Stephen Pelton, Boston Medical Center:

Primary Outcome Measures:
  • Nasopharngeal Colonization With PCV13 S. Pneumoniae [ Time Frame: Study years 1-5 ]
    Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae


Biospecimen Retention:   Samples With DNA
NP specimens and bacterial isolates of S. pneuomoniae and nontypable Haemophilus

Enrollment: 9000
Study Start Date: April 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children <2 years of age
Children <2 years of age with and without respiratory tract infection
Children 2<5 years of age
Children 2<5 years of age with and without respiratory tract infection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109108


Locations
United States, Massachusetts
Pediatric Primary Care, Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Stephen Pelton, Professor of Pediatrics and Epidemiology, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01109108     History of Changes
Other Study ID Numbers: H-28757
First Submitted: April 21, 2010
First Posted: April 22, 2010
Results First Submitted: January 25, 2017
Results First Posted: March 14, 2017
Last Update Posted: March 14, 2017
Last Verified: January 2017

Keywords provided by Stephen Pelton, Boston Medical Center:
pneumococcal vaccine
nasopharyngeal carriage

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections