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Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

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ClinicalTrials.gov Identifier: NCT01109108
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : March 14, 2017
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stephen Pelton, Boston Medical Center

Brief Summary:

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 or disease
Nasopharyngeal Carriage of S. Pneumoniae

Study Type : Observational
Actual Enrollment : 9000 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
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



Primary Outcome Measures :
  1. 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


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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.

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 Posted: April 22, 2010    Key Record Dates
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