Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Richard Adegbola


Contact details

MRC Laboratories
Atlantic Boulevard
P O Box 273
+220 449 4491

Additional identifiers

EudraCT number number

Protocol/serial number

SCC 1032

Study information

Scientific title


Vilage study

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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Pneumococcal infection or colonisation


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.

Intervention type



Not Specified

Drug names


Primary outcome measure

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 measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Resident of one of 21 Gambian villages

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

MRC Laboratories

Sponsor information


Medical Research Council (UK)

Sponsor details

20 Park Crescent
United Kingdom
+44 (0)20 7636 5422

Sponsor type

Research council



Funder type

Research council

Funder name

Medical Research Council (UK) - core funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Wyeth Pharmaceutical Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2012 antibody concentration results in:
2. 2012 nasopharyngeal carrieage results in:
3. 2012 indirect effect results in:
4. 2013 results in:

Publication citations

  1. Antibody concentration results

    Ota MO, Roca A, Bottomley C, Hill PC, Egere U, Greenwood B, Adegbola RA, Pneumococcal antibody concentrations of subjects in communities fully or partially vaccinated with a seven-valent pneumococcal conjugate vaccine., PLoS ONE, 2012, 7, 8, e42997, doi: 10.1371/journal.pone.0042997.

  2. Nasopharyngeal carrieage results

    Roca A, Bottomley C, Hill PC, Bojang A, Egere U, Antonio M, Darboe O, Greenwood BM, Adegbola RA, Effect of age and vaccination with a pneumococcal conjugate vaccine on the density of pneumococcal nasopharyngeal carriage., Clin. Infect. Dis., 2012, 55, 6, 816-824, doi: 10.1093/cid/cis554.

  3. Indirect effect results

    Egere U, Townend J, Roca A, Akinsanya A, Bojang A, Nsekpong D, Greenwood B, Adegbola RA, Hill PC, Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal carriage in newborns in rural Gambia: a randomised controlled trial., PLoS ONE, 2012, 7, 11, e49143, doi: 10.1371/journal.pone.0049143.

  4. Results

    Roca A, Dione MM, Bojang A, Townend J, Egere U, Darboe O, Howie SR, Hill PC, Adegbola RA, Greenwood BM, Antonio M, Nasopharyngeal carriage of pneumococci four years after community-wide vaccination with PCV-7 in The Gambia: long-term evaluation of a cluster randomized trial., PLoS ONE, 2013, 8, 9, e72198, doi: 10.1371/journal.pone.0072198.

Additional files

Editorial Notes