Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)
Condition: Malaria,Falciparum; Children, Only
MeSH terms: Malaria; Malaria, Falciparum
Intervention: RABIPUR®; RTS,S/AS01; SMC with SP+AQ; SMC placebo
Intervention description: Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June); Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June); Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses.; Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, individually randomised trial to compare the incidence of clinical episodes of malaria across three study arms:
Seasonal vaccination with the malaria vaccine RTS,S/AS01
Seasonal malaria chemoprevention with SP/AQ
Combination of these two interventions
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 5920.0
Sex: All
Minimum age: 5 Months
Maximum age: 17 Months
Healthy volunteers: No
Keywords: Malaria; Seasonal vaccination; Seasonal chemoprevention

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.
    

Eligibility 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