Pediatric Primary Care, Boston Medical Center
Boston, Massachusetts, 02118, United States
Completed
NCT Number: NCT01109108
Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
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.
Completed
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Boston Medical Center
Other
Collaborators
- Merck Sharp & Dohme LLC
Registry information
Official study 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
Important dates
- Study start
- 2010
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 22, 2010
- Registry last updated
- Mar 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.