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

April 21, 2010
November 17, 2010
April 2010
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01109108 on ClinicalTrials.gov Archive Site
Not Provided
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Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
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

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate

Nasopharyngeal Carriage of S. Pneumoniae
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5000
April 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01109108
H-28757
No
Stephen I. Pelton, Boston Medical Center
Boston Medical Center
  • Thrasher Research Fund
  • Pfizer
Not Provided
Boston Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP