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NCT01040143 Clinical Trial

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

Pneumococcal Disease Clinical Trial

— Pneucast  

Official title:
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01040143
Other study ID # PneuCaSt
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2008
Est. completion date March 2010

Study information
Verified date September 2010
Source Public Health England
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Health Protection Agency Gloucester
United Kingdom Health Protection Agency London
United Kingdom Health Protection Agency Stevenage Hertfordshire

Sponsors (1)
Lead Sponsor Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

van Hoek AJ, Sheppard CL, Andrews NJ, Waight PA, Slack MP, Harrison TG, Ladhani SN, Miller E. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine. 2014 Jul 23; — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of pneumococci in nasopharyngeal swabs
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