Malaria
Conditions
Interventions
Sulphadoxine Pyrimethamine plus Amodiaquine and Malaria RTS.S Vaccine
Sulphadoxine Pyrimethamine plus Placebo Tablets
Placebo tablets plus Malaria RTS.S Vaccine
Sponsors
PATH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of a signed and dated informed consent form by a parent or guardian. 2. A statement by the parent or guardian of a willingness to comply with all study procedures and of their availability for the duration of the study. 3. Aged 14 - 18 weeks at enrollment. 4. The infant is in good general health as evidenced by their medical history and by a physical examination. 5. The infant is able to take oral medication.
Exclusion criteria
Exclusion criteria: 1. Current use of a disallowed concomitant medications. 2. Current participation in another intervention trial. 3. Prior administration of a malaria vaccine. 4. Known allergic reactions to components of SP, AQ or to RTSS/AS01 E . 5. Any other condition(s) or diagnosis, or physical examination finding that precludes participation as assessed by a study clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Clinical Malaria | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of severe malaria;Incidence of all-cause hospital admissions or deaths, excluding external causes and elective surgical conditions.;Prevalence of under nutrition (any level of underweight and stunting) | — |
Countries
Ghana
Contacts
Public ContactSamuel Harrison
Clinical Research Fellow Kintampo Health Research Centre
Outcome results
None listed