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
Sponsor:
Collaborators:
Thrasher Research Fund
Pfizer
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01109108
First received: April 21, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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.


Condition
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)
Groups/Cohorts
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Stephen I. Pelton, Boston Medical Center
ClinicalTrials.gov 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:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 16, 2014