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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:
ClinicalTrials.gov Identifier:
NCT01040143
First Posted: December 29, 2009
Last Update Posted: September 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Public Health England
  Purpose
A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.

Condition
Pneumococcal Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci

Resource links provided by NLM:


Further study details as provided by Public Health England:

Primary Outcome Measures:
  • Presence of pneumococci in nasopharyngeal swabs

Estimated Enrollment: 450
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community samples taken within the home of eligible subjects.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040143


Locations
United Kingdom
Health Protection Agency
Stevenage, Hertfordshire, United Kingdom
Health Protection Agency
Gloucester, United Kingdom
Health Protection Agency
London, United Kingdom, NW9 5HT
Sponsors and Collaborators
Public Health England
  More Information

Additional Information:
Responsible Party: Professor Elizabeth Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT01040143     History of Changes
Other Study ID Numbers: PneuCaSt
First Submitted: December 28, 2009
First Posted: December 29, 2009
Last Update Posted: September 3, 2010
Last Verified: September 2010

Keywords provided by Public Health England:
Pneumococci
Streptococcus pneumoniae

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections