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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
ISRCTN ISRCTN51695599
DOI 10.1186/ISRCTN51695599
ClinicalTrials.gov identifier
EudraCT number
Public title Community randomised controlled trial to assess the impact of vaccination with a pneumococcal conjugate vaccine on nasopharyngeal carriage of pneumococci in the Gambia
Scientific title
Acronym Vilage study
Serial number at source SCC 1032
Study hypothesis It is likely that Prevenar®, a seven-valent pneumococcal conjugate vaccine, will soon be introduced into childhood immunisation programme in The Gambia. Pneumococci of serotypes 1 or 5 are important causes of invasive disease in The Gambia but are found infrequently in the nasopharynx and are not contained in Prevenar®. Could introduction of Prevenar® enhance their ability to establish themselves in the nasopharynx and subsequently to cause invasive disease?

In order to study the effects of maximum immune pressure of the kind that will be seen only several years after routine use of the vaccine, we propose to study the effects of vaccination of a whole community as well as that of vaccinating just the infant population.
Lay summary Not provided at time of registration
Ethics approval The Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee, approved on 27/02/2006, reference number: SCC 1032
Study design Community randomised controlled pneumococcal vaccination trial
Countries of recruitment Gambia
Disease/condition/study domain Pneumococcal infection or colonisation
Participants - inclusion criteria Resident of one of 21 Gambian villages
Participants - 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
Anticipated start date 01/07/2006
Anticipated end date 01/07/2009
Status of trial Completed
Patient information material
Target number of participants 7,500
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. Infants under the age of three months and all children aged up to 11 months at the time that the study starts will receive three doses of vaccine at monthly intervals during the next three-month period. Children aged 12 - 30 months will receive two doses of pneumococcal conjugate vaccine given at an interval of a month. All subjects above the age of 30 months living in villages in group one will receive a single dose of pneumococcal conjugate vaccine; those living in group two villages will receive a single dose of control vaccine.
Primary outcome measure(s) 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
Secondary outcome measure(s) 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
Sources of funding 1. Medical Research Council (UK) - core funding
2. Wyeth Pharmaceutical Inc. (USA)
Trial website
Publications 1. 2012 antibody concentration results in: http://www.ncbi.nlm.nih.gov/pubmed/22916192
2. 2012 nasopharyngeal carrieage results in: http://www.ncbi.nlm.nih.gov/pubmed/22700830
3. 2012 indirect effect results in: http://www.ncbi.nlm.nih.gov/pubmed/23185303
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24086259
Contact name Prof  Richard  Adegbola
  Address MRC Laboratories
Atlantic Boulevard
Fajara
P O Box 273
  City/town Banjul
  Zip/Postcode -
  Country Gambia
  Tel +220 449 4491
  Fax +220 449 7924
  Email radegbola@mrc.gm
Sponsor Medical Research Council (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email tcorrah@mrc.gm
  Sponsor website: http://www.mrc.ac.uk
Date applied 02/06/2006
Last edited 04/10/2013
Date ISRCTN assigned 04/08/2006
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