Assessing the RTS,S malaria vaccine's safety and effectiveness in young children in Africa
A Prospective Study to Evaluate the Safety, Effectiveness and Impact of the RTS, S/AS01E Vaccine in Young Children in Sub-Saharan Africa
This study is testing the safety and effectiveness of the RTS,S malaria vaccine in young children in Africa to see how well it protects them from malaria compared to those who don’t get the vaccine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 78000 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 7 sites (Kintampo and 6 other locations) |
| Trial ID | NCT03855995 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the RTS,S/AS01E malaria vaccine's safety and effectiveness in young children across sub-Saharan Africa. It involves active surveillance and enhanced hospitalization monitoring to compare adverse events and malaria occurrences between vaccinated and unvaccinated children in both exposed and unexposed clusters. The study aims to enroll at least 45,000 children, with data collected uniformly to assess the vaccine's overall impact on health outcomes. The findings will contribute to understanding the vaccine's role in routine immunization programs.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 months living in specific surveillance areas in sub-Saharan Africa who have received at least one dose of DTP/HepB/Hib vaccine.
Not a fit: Patients who are older than 18 months or have not received any doses of DTP/HepB/Hib vaccine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the RTS,S malaria vaccine's effectiveness, potentially leading to improved malaria prevention strategies for children.
How similar studies have performed: Previous studies on malaria vaccines have shown promise, but this specific approach of assessing the RTS,S vaccine in a large cohort is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria All study participants must satisfy ALL the following criteria at study entry: * Study participants' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent provided from either the parent(s) or LAR of the study participant. * Study participant living in the HDSS or equivalent surveillance system area. * For enrolment in the active surveillance - DTP group: children must be aged less than (\<) 18 months, identified at any administration of DTP/HepB/Hib (or at hospitalisation before 3rd dose of DTP/HepB/Hib in case of hospitalisation and vaccinated with at least one dose of DTP/HepB/Hib). (This group will include children from exposed and unexposed clusters.) OR For enrolment in the active surveillance - Catch-up group: children must be aged \<18 months, received at least one dose of DTP/HepB/Hib vaccine, whose age corresponds to the age after the 3rd dose of DTP/HepB/Hib vaccine, (=who either received all DTP/HepB/Hib doses before study start or received at least one dose of DTP/HepB/Hib and are older than the age corresponding to the 3rd DTP/HepB/Hib dose at study start) and identified at 1st RTS,S/AS01E dose administration (This group will include children from exposed clusters only). OR For enrolment in the enhanced hospitalisation surveillance: children must be aged at least 6 weeks and \<5 years at the time of hospitalisation at any time during the study. (This group will include children from exposed and unexposed clusters.) Parents/LARs of children meeting all eligibility criteria for active surveillance, not having completed the visits for DTP/HepB/Hib, and first identified during hospitalisation, must first be proposed enrolment in active surveillance (if recruitment is not completed). Children already enrolled in active surveillance will have hospitalization monitored as part of the procedures related to the active surveillance and can therefore not be enrolled in enhanced hospitalization surveillance. Exclusion Criteria: • Child in care = A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
Where this trial is running
Kintampo and 6 other locations
- GSK Investigational Site — Kintampo, Ghana (Recruiting)
- GSK Investigational Site — Navrongo, Ghana (Recruiting)
- GSK Investigational Site — Kisumu, Kenya (Recruiting)
- GSK Investigational Site — Kisumu, Kenya (Recruiting)
- GSK Investigational Site — Kisumu, Kenya (Recruiting)
- GSK Investigational Site — Chikwawa, Malawi (Recruiting)
- GSK Investigational Site — Mangochi, Malawi (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.