Nasopharyngeal Carriage of S. Pneumoniae Clinical Trial
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
| Verified date | November 2010 |
| Source | Boston Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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 and their parents.
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.
| Status | Active, not recruiting |
| Enrollment | 5000 |
| Est. completion date | April 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Boston Medical Center | Pfizer, Thrasher Research Fund |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | serotype specific colonization with S. pneumoniae | track the changes in serotypes in nasopharynx following introduction of PCV13 | 2 years | No |