Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105646878477 Date of Approval: 06/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pneumococcal Vaccine Schedules
Official scientific title A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine in rural Gambia
Brief summary describing the background and objectives of the trial Pneumococcus bacteria are the most common cause of pneumonia (lung inflammation), septicemia (bacteria in the blood) and meningitis (inflammation of the membranes around the brain) worldwide. Many countries have introduced pneumococcal conjugate vaccines (PCV) using three or four dose schedules and this has been followed by a drop in pneumococcal disease. Herd protection effects, in which vaccinatiuon of a proportion of the population reduces the spread of a disease within the unvaccinated population, have prevented more cases than the direct effects in vaccinated children. Many African and Asian countries have now introduced PCV using the standard schedule of three doses in early infancy (3+0 schedule). Global control of pneumococcal disease however, is hampered by the cost of PCV. Low-income countries receive subsidised vaccine through the Gavi Alliance. However, when countries’ income per person exceeds the World Bank ‘low-income’ threshold, they ‘graduate’ from Gavi support and must pay a proportion of the cost. The cost of vaccine has prevented most middle-income countries from introducing PCV. This study will test an alternative schedule that includes one early dose and a booster dose at 9 months of age, compared to the standard schedule. If this two-dose schedule is as effective as the three-dose schedule, this would make the cost of vaccinating lower. We aim to test if the impact of the alternative schedule is not worse than the standard schedule.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PVS
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied pneumococci
Purpose of the trial impact of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine in rural Gambia
Anticipated trial start date 01/11/2018
Actual trial start date 22/08/2019
Anticipated date of last follow up 27/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SCC 1577 MRCG at LSHTM Scientific Coordinating Committee
LSHTM EC Ref 14515 LSHTM Ethics Committee
15056916 ISRCTN
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group pneumococcal conjugate vaccine 3 48months 13-valent pneumococcal conjugate vaccine (PCV13) is a licenced product, procured by the Gambia Government EPI, delivered in two schedules, one with doses scheduled at ages 6, 10 and 14 weeks (3+0 schedule) and the other with doses scheduled at ages 6 weeks and 9 months (1+1 schedule). 20000 Dose Comparison
Experimental Group pneumococcal conjugate vaccine 2 48months 13-valent pneumococcal conjugate vaccine (PCV13) is a licenced product, procured by the Gambia Government EPI, delivered in two schedules, one with doses scheduled at ages 6, 10 and 14 weeks (3+0 schedule) and the other with doses scheduled at ages 6 weeks and 9 months (1+1 schedule). 20000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Resident in the study area Intent to move out of the study area before 4 months of age. Age greater than 9 months Completed PCV schedule Contraindication to PCV13 – severe hypersensitivity to a previous dose of PCV13 Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 2 Week(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/02/2018 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Fajara Fajara 273 Gambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/02/2018 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nasopharyngeal (NP) carriage of vaccine-type (VT) pneumococci in children aged 2 weeks - 59 months with clinical pneumonia. 2nd and 4th year of the trial.
Secondary Outcome .NP carriage of non-vaccine-type (NVT) pneumococci in children aged 2 weeks - 59 months with clinical pneumonia. • Population-based NP prevalence of VT and NVT pneumococci with measurement of interpersonal contact patterns. • NP prevalence of VT and NVT pneumococci in infants presenting for the first dose of PCV aged 6 – 12 weeks. • Incidence of radiological pneumonia in children aged 2 weeks - 59 months. • Incidence of clinical pneumonia in children aged 2 weeks - 59 months. • Incidence of clinical pneumonia with NP carriage of VT pneumococci in children aged 2 weeks – 59 months • Incidence of serotype-specific IPD in children aged 2 weeks - 59 months. • Incidence of hospitalisation in children aged 2 weeks – 59 months. • Mortality in children aged 2 weeks - 59 months. troughout the trial, 2nd and 4th year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Basse Field Station MRCG at LSHTM Basse Field Station, MRCG at LSHTM Upper River Region Basse Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical research Council Uk N/A London United Kingdom
Wellcome Trust N/A London United Kingdom
National Institute for Health Research UK N/A London United Kingdom
Bill and Melinda Gates Foundation N/A Seattle Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom University / Research Organistaion
COLLABORATORS
Name Street address City Postal code Country
Gambia Government Expanded Programme on Immunisation Bertil Harding Highway Kotu Gambia
London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom
St Georges University of London Institute of Infection and Immunity Cranmer Terrace London United Kingdom
Murdoch Childrens Research Institute New Vaccines Flemington Road Melbourne Australia
Finland National Institute for Health and Welfare N/A Helsinki Finland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Grant Mackenzie gmackenzie@mrc.gm 002207207826 N/A
City Postal code Country Position/Affiliation
Basse Gambia Clinical Epidemiologist Paediatrician at MRCG at LSHTM
Role Name Email Phone Street address
Public Enquiries Jama Jack jjack@mrc.gm 002204495442 Atlantic Road
City Postal code Country Position/Affiliation
Fajara N/A Gambia Head of Communications MRCG at LSHTM
Role Name Email Phone Street address
Scientific Enquiries Grant Mackenzie gmackenzie@mrc.gm 002207207826 N/A
City Postal code Country Position/Affiliation
Basse N/A Gambia Clinical Epidemiologist Paediatrician at MRCG at LSHTM
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised datasets will be available indefinitely after publications of results. Data will be accessible by application to the MRCG at LSHTM scientific coordinating committee. Participant consent will be obtained. Approval of the Gambia government/MRCG at LSHTM joint ethics committee is required for data to be sent out of the country Informed Consent Form,Statistical Analysis Plan,Study Protocol indefinitely after publications of results Requests for access to the complete dataset will need to be made to the Unit’s Archives department who will then forward it to the Scientific Coordinating Committee (SCC) of the Unit. All requests for the dataset will be reviewed by the SCC and also by The Gambia Government/MRC Joint Ethics Committee to establish that the request is in order to perform scientifically appropriate analysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information