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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51695599
Enrollment
7500
Registered
2006-08-04
Start date
2006-07-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal infection or colonisation Infections and Infestations Pneumococcal infection

Interventions

All young children who enter the trial will receive three doses of pneumococcal conjugate vaccine given at ages 2, 3 and 4 months through the Expanded Programme on Immunisation (EPI) programme. Infant
those living in group two villages will receive a single dose of control vaccine.

Sponsors

Medical Research Council (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Resident of one of 21 Gambian villages

Exclusion criteria

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

Design outcomes

Secondary

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

Primary

MeasureTime frame
1. Differences in the prevalence of nasopharyngeal carriage of pneumococci of vaccine or of non-vaccine serotype in study villages after vaccination 2. Differences in the prevalence of carriage with serotype 1 and serotype 5 pneumococci will be of particular importance

Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026