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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:
Public Health England
ClinicalTrials.gov Identifier:
NCT01040143
First received: December 28, 2009
Last updated: September 2, 2010
Last verified: September 2010

December 28, 2009
September 2, 2010
January 2008
March 2010   (final data collection date for primary outcome measure)
Presence of pneumococci in nasopharyngeal swabs [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01040143 on ClinicalTrials.gov Archive Site
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A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.
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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample
Community samples taken within the home of eligible subjects.
Pneumococcal Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
1 Year and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01040143
PneuCaSt
No
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Professor Elizabeth Miller, Health Protection Agency
Public Health England
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Public Health England
September 2010

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