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
  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

Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Presence of pneumococci in nasopharyngeal swabs [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Health Protection Agency, United Kingdom
  More Information

Additional Information:
No publications provided

Responsible Party: Professor Elizabeth Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT01040143     History of Changes
Other Study ID Numbers: PneuCaSt
Study First Received: December 28, 2009
Last Updated: September 2, 2010
Health Authority: United Kingdon: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
Pneumococci
Streptococcus pneumoniae

ClinicalTrials.gov processed this record on August 21, 2014