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

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether the malaria vaccine RTS,S/AS01 is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso; Malaria Research and Training Center, Bamako, Mali
• Treatments: Amodiaquine; Sulfadoxine; Vaccines

Criteria

Inclusion Criteria:

• 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 5 - 17 months of age at the time of first vaccination

• A parent or legally recognised guardian provides informed consent for the child to join the trial

Exclusion Criteria:

• The child is a transient resident in the study area

• The child is in care

• The age of the child is outside the stipulated range

• The child has a history of an adverse reaction to SP or AQ

• The child has a serious underlying illness, including known HIV infection, unless this is well controlled by treatment, or severe malnutrition (weight for age or mid arm circumference Z scores < 3 SD)

• The child is known to have an immune deficiency disease or is receiving an immunosuppressive drug

• The child has previously received a malaria vaccine.

• The child is enrolled in another malaria intervention trial

• The parents or guardians do not provide informed consent