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 | https://doi.org/10.1186/ISRCTN51695599 |
| Secondary identifying numbers | SCC 1032 |
- Submission date
- 02/06/2006
- Registration date
- 04/08/2006
- Last edited
- 04/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Richard Adegbola
Scientific
Scientific
MRC Laboratories
Atlantic Boulevard
Fajara
P O Box 273
Banjul
-
Gambia
| Phone | +220 449 4491 |
|---|---|
| radegbola@mrc.gm |
Study information
| Study design | Community randomised controlled pneumococcal vaccination trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | Vilage study |
| Study objectives | 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(s) | The Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee, approved on 27/02/2006, reference number: SCC 1032 |
| Health condition(s) or problem(s) studied | Pneumococcal infection or colonisation |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prevenar® |
| 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 study start date | 01/07/2006 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 7,500 |
| Key inclusion criteria | Resident of one of 21 Gambian villages |
| Key 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 |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Gambia
Study participating centre
MRC Laboratories
Banjul
-
Gambia
-
Gambia
Sponsor information
Medical Research Council (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| tcorrah@mrc.gm | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (UK) - core funding
No information available
Wyeth Pharmaceutical Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | indirect effect results | 01/09/2012 | Yes | No | |
| Results article | nasopharyngeal carrieage results | 01/09/2012 | Yes | No | |
| Results article | antibody concentration results | 01/12/2012 | Yes | No | |
| Results article | results | 27/09/2013 | Yes | No |
