NCT04319380View on ClinicalTrials.gov

Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study

PHASE3CompletedINTERVENTIONAL
Enrollment

5,098

Participants

Timeline

Start Date

April 1, 2020

Primary Completion Date

March 31, 2022

Study Completion Date

March 31, 2022

Conditions
Malaria,FalciparumChild, Only
Interventions
BIOLOGICAL

Tetanus/diphtheria toxoids

One dose of tetanus/diphtheria toxoids vaccine (June) in year 1 and year 2.

DRUG

SMC with SP+AQ

Year 1 and 2 (2020/21) Four cycles of SMC (SP+AQ) (July, August, September, October). One cycle of SMC consisting of sulphadoxine - pyrimethamine (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3.

BIOLOGICAL

RTS,S/AS01

One booster dose of RTSS/AS01 (June) in year 1 and 2.

DRUG

SMC placebo

Year 1 and 2 (2020/21) Four cycles of SMC placebo (July, August, September, October)

Trial Locations (2)

Unknown

Institut de Recherche en Sciences de la Santé, Ouagadougou

Malaria Research & Training Center, Bamako

All Listed Sponsors
collaborator

Malaria Research and Training Center, Bamako, Mali

OTHER

collaborator

Institut de Recherche en Sciences de la Sante, Burkina Faso

OTHER_GOV

lead

London School of Hygiene and Tropical Medicine

OTHER

NCT04319380 - Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study | Biotech Hunter | Biotech Hunter