Status:
ACTIVE_NOT_RECRUITING
A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Malaria Vaccines
Eligibility:
All Genders
Up to 5 years
Brief Summary
The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been ...
Detailed Description
This is a disease surveillance study with prospective cohort event monitoring including both temporal and concurrent comparisons of the occurrence of adverse and malaria events between vaccinated and ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
77969 Patients enrolled
Trial Details
Trial ID
NCT03855995
Start Date
March 21 2019
End Date
August 11 2025
Last Update
August 7 2025
Active Locations (6)
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1
GSK Investigational Site
Kintampo, Ghana
2
GSK Investigational Site
Navrongo, Ghana
3
GSK Investigational Site
Kisumu, Kenya, 4 0100
4
GSK Investigational Site
Kisumu, Kenya, 40100