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Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stephen Pelton, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01109108
First received: April 21, 2010
Last updated: January 25, 2017
Last verified: January 2017

April 21, 2010
January 25, 2017
April 2010
March 2015   (Final data collection date for primary outcome measure)
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
serotype specific colonization with S. pneumoniae [ Time Frame: 2 years ]
track the changes in serotypes in nasopharynx following introduction of PCV13
Complete list of historical versions of study NCT01109108 on ClinicalTrials.gov Archive Site
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Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
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

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.

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Observational
Observational Model: Other
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
NP specimens and bacterial isolates of S. pneuomoniae and nontypable Haemophilus
Non-Probability Sample
children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate
Nasopharyngeal Carriage of S. Pneumoniae
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9000
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01109108
H-28757
No
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Stephen Pelton, Boston Medical Center
Boston Medical Center
Merck Sharp & Dohme Corp.
Not Provided
Boston Medical Center
January 2017

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