N/A
Completed N=8,790
Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
Nasopharyngeal Carriage of S. Pneumoniae
Source: ClinicalTrials.gov NCT01109108 ↗
Enrolled (actual)
8,790
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Nasopharngeal Colonization With PCV13 S. Pneumoniae — 20; 31; 166; 137 Participants — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nasopharngeal Colonization With PCV13 S. Pneumoniae |
20; 31; 166; 137; 23; 11 | <0.05 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01109108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.