A Study to Evaluate the Safety, Effectiveness and Impact of the GlaxoSmithKline Biologicals' Malaria Vaccine- RTS, S/AS01E in Young Children in Sub-Saharan Africa
About the study
Who can take part
INCLUSION CRITERIA
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
Exclusion Criteria:
• Child in care
Study Locations
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How to Apply
Study Details
Contition
Malaria,Malaria Vaccines
Age
< 5
Participants Needed
78000
Est. Completion Date
May 26, 2025
Treatment Type
OBSERVATIONAL
Sponsor
GlaxoSmithKline
ClinicalTrials.gov NCT Identifier
NCT03855995
Study Number
115056
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