Community randomised controlled trial to assess the impact of vaccination with a pneumococcal conjugate vaccine on nasopharyngeal carriage of pneumococci in the Gambia

Completed

• Conditions: Pneumococcal infection or colonisation; Infections and Infestations; Pneumococcal infection

• Registration Number: ISRCTN51695599
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

Resident of one of 21 Gambian villages

Exclusion Criteria

1. Failure of the family/subject to give consent
2. Non-residence in the villages
3. Declared intent of the family/subject to leave the study area permanently within the following three months
4. Previous exposure to a conjugate pneumococcal vaccine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Differences in the prevalence of nasopharyngeal carriage of pneumococci of vaccine or of non-vaccine serotype in study villages after vaccination<br>2. Differences in the prevalence of carriage with serotype 1 and serotype 5 pneumococci will be of particular importance

Secondary Outcome Measures

Name	Time	Method
1. Acquisition rates of nasopharyngeal carriage in newborns resident in vaccinated or control villages<br>2. Evidence for an increased rate of capsular switching in villages where community-wide pneumococcal conjugate vaccination has been introduced<br>3. Measurements of Immunoglobulin G (IgG) and Immunoglobulin A (IgA) levels in serum and saliva