Status:
COMPLETED
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Malaria Research and Training Center, Bamako, Mali
Institut de Recherche en Sciences de la Sante, Burkina Faso
Conditions:
Malaria,Falciparum
Child, Only
Eligibility:
All Genders
3-5 years
Phase:
PHASE3
Brief Summary
A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seaso...
Detailed Description
Although there has been substantial progress in malaria control in the past decade, this progress has stalled in many countries in sub-Saharan Africa, especially in countries of the Sahel and central ...
Eligibility Criteria
Inclusion
- The child had been enrolled in the initial phase of the trial of seasonal vaccination with the RTS,S/AS01 vaccine
- A parent or legally recognised guardian provides informed consent for the child's inclusion in the extension study
- The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial
- The child is under five years of age at the time of enrolment.
Exclusion
- The child has had an allergic reaction to the study drugs or vaccines
- The child had febrile convulsions on more than one occasion following vaccination
- The child has developed a serious underlying illness such as severe malnutrition (weight for age or mid arm circumference Z scores \< 3 SD) which in view of the investigators might impair the response to vaccination
- The child has been enrolled in another malaria vaccine or other experimental malaria intervention study
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
5098 Patients enrolled
Trial Details
Trial ID
NCT04319380
Start Date
April 1 2020
End Date
March 31 2022
Last Update
September 20 2024
Active Locations (2)
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1
Institut de Recherche en Sciences de la Santé
Ouagadougou, Direction Régionale de l'Ouest, Burkina Faso
2
Malaria Research & Training Center
Bamako, Mali