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
Protocol serial number	SCC 1032
Sponsor	Medical Research Council (UK)
Funders	Medical Research Council (UK) - core funding, Wyeth Pharmaceutical Inc. (USA)

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

MRC Laboratories
Atlantic Boulevard
Fajara
P O Box 273
Banjul
-
Gambia

Phone	+220 449 4491
Email	radegbola@mrc.gm

Study information

Primary study design	Interventional
Study design	Community randomised controlled pneumococcal vaccination trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prevenar®
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
Key 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
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	7500
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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