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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 21, 2010
Last Updated Date	November 17, 2010
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 21, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01109108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
Official Title ^ICMJE	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
Brief 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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: NP specimens and bacterial isolates of S. pneuomoniae and nontypable Haemophilus
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
Condition ^ICMJE	Nasopharyngeal Carriage of S. Pneumoniae
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	5000
Estimated Completion Date	April 2013
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01109108
Other Study ID Numbers ^ICMJE	H-28757
Has Data Monitoring Committee	No
Responsible Party	Stephen I. Pelton, Boston Medical Center
Study Sponsor ^ICMJE	Boston Medical Center
Collaborators ^ICMJE	Thrasher Research Fund Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	Boston Medical Center
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top