A study to assess the impact of the pneumococcal conjugate vaccination programme on carriage of pneumococci in children eligible for vaccination and their household contacts

Not Applicable

Completed

Conditions: Invasive Pneumococcal Disease
Infections and Infestations
Streptococcal infection, unspecified site

Registration Number: ISRCTN05935832

Lead Sponsor: Health Protection Agency (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. At least one child aged 1 to 5 years in the household
2. Written informed consent obtained for the child's parent/legal guardian and participating household contacts

Exclusion Criteria

1. Moderate to severe cerebral palsy or other debilitating condition
2. Syndromes and neurological disorders affecting swallowing
3. Ear, nose & throat disorders affecting local anatomy for swabbing (e.g. malformed ears)
4. Confirmed or suspected immunodeficiency (congenital or acquired) or on immunosuppressive therapy

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pneumococcal carriage rates for PCV13 and non-PCV13 serotypes in children aged <5 years two years after the introduction of PCV13<br>2. Pneumococcal carriage rates for PCV13 and non PCV13 serotypes in older children and adolescents (aged 5-20 years) and adults (aged >20 years) two years after the introduction of PCV13<br>3. Invasiveness of any emerging replacement carriage serotypes by estimating case: carrier ratio (CCR) using national surveillance data for invasive pneumococcal disease

Secondary Outcome Measures

Name	Time	Method
1. Carriage rates of individual serotypes<br>2. Compare carriage by PCV7/PCV13 vaccination status in vaccine eligible cohorts<br>3. Compare, by age-group, changes in carriage serotypes with previous carriage studies performed by the HPA in 2001/02 and 2008/09 in children and adults