Pneumococcal infection or colonisation Infections and Infestations Pneumococcal infection
Conditions
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)
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
| Measure | Time 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
| Measure | Time 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