Overview
The RTS, S/AS01E vaccine has been developed for routine immunization of children living in malaria- endemic countries of sub-Saharan Africa. This study is intended as a post-implementation safety study (after vaccine implementation), with the primary objective to evaluate the safety of vaccine after its administration. In addition to the primary objective, the study will also evaluate the impact and effectiveness of the vaccine.
Description
Active surveillance refers to prospective cohort monitoring of the AESI and other diseases during study follow-up visits at the community level as well outpatient and inpatient visits.
Enhanced hospitalisation surveillance (EHS) is defined as case detection during hospitalisation through monitoring of medical records and registries for the study participants not enrolled in active surveillance.
The study targets enrolling at least 45,000 children in active surveillance (AS), including 22,500 in the exposed clusters and 22,500 in the unexposed clusters for evaluation of the vaccine safety, effectiveness and impact. In the exposed clusters are included a minimum of 20,250 children vaccinated with RTS,S/AS01E for evaluation of the vaccine safety, and a minimum of 2,250 unvaccinated children for evaluation of effectiveness and impact assuming that 80% of the 22,500 study participants will receive three doses of RTS,S/AS01E, 10% will receive one or two doses and 10% will not have any dose.
The Malaria Vaccine Implementation Programme (MVIP) is considering implementing the malaria vaccine in unexposed clusters as from 2023. This decision will directly impact the temporal (before/after) and concurrent (exposed versus unexposed clusters) comparisons. Based on this, the EHS recruitment will be stopped as from 01 January 2023 in sites that were not involved in the NCT02374450 study and study conclusion will be conducted in a timely manner for already enrolled subjects in those sites (EHS will stop in all sites in Malawi, Siaya and Nyando sites in Kenya and unexposed sites in Ghana).
Eligibility
Inclusion Criteria:
- 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 <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 and identified at administration of first dose of RTS,S/AS01E vaccine (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.) Parent(s)/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 hospitalisation monitored as
part of the procedures related to the active surveillance and can therefore not be enrolled
in enhanced hospitalisation surveillance.
Exclusion Criteria:
• Child in care