Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage (no)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Boston Medical Center.
Recruitment status was  Active, not recruiting
Thrasher Research Fund
Information provided by:
Boston Medical Center Identifier:
First received: April 21, 2010
Last updated: November 17, 2010
Last verified: November 2010

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.

Nasopharyngeal Carriage of S. Pneumoniae

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • serotype specific colonization with S. pneumoniae [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    track the changes in serotypes in nasopharynx following introduction of PCV13

Biospecimen Retention:   Samples Without DNA

NP specimens and bacterial isolates of S. pneuomoniae and nontypable Haemophilus

Estimated Enrollment: 5000
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
children < 2 years of age
children less than 2 years of age
children 2 - 5 years of age
children 2-5 years of age
parents of chldren
parents of children


Genders Eligible for Study:   Both
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


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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Stephen I. Pelton, Boston Medical Center Identifier: NCT01109108     History of Changes
Other Study ID Numbers: H-28757
Study First Received: April 21, 2010
Last Updated: November 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
pneumococcal vaccine
nasopharyngeal carriage

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on February 27, 2015