A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci (Pneucast)

This study has been completed.

Sponsor:

Information provided by:

Health Protection Agency, United Kingdom

ClinicalTrials.gov Identifier:

NCT01040143

First received: December 28, 2009

Last updated: September 2, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 28, 2009
Last Updated Date	September 2, 2010
Start Date ^ICMJE	January 2008
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 28, 2009)	Presence of pneumococci in nasopharyngeal swabs [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01040143 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	A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
Official Title ^ICMJE	A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
Brief Summary	A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Community samples taken within the home of eligible subjects.
Condition ^ICMJE	Pneumococcal Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
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	Completed
Estimated Enrollment ^ICMJE	450
Completion Date	March 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or Written informed consent given by the subject after the nature of the study has been explained to them Exclusion Criteria: Moderate to severe disability. Cerebral palsy, syndromes and neurological disorders affecting swallowing. Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears. Confirmed or suspected immunodeficiency (congenital or acquired). On immunosuppressive therapy.
Gender	Both
Ages	1 Year and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01040143
Other Study ID Numbers ^ICMJE	PneuCaSt
Has Data Monitoring Committee	No
Responsible Party	Professor Elizabeth Miller, Health Protection Agency
Study Sponsor ^ICMJE	Health Protection Agency, United Kingdom
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Health Protection Agency, United Kingdom
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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