This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the malaria vaccine candidates R78C with Matrix-Mâ„¢, and the combination of RH5.1 and R21 with Matrix-Mâ„¢, in children aged 5-36 months in Burkina Faso.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Efficacy: The primary efficacy outcome is clinical malaria, defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density >5000 asexual forms/µL.
Timeframe: Clinical malaria will be assessed 6 months post final vaccination
Safety: To assess the safety and reactogenicity of R78C, RH5.1 and R21 with Matrix-Mâ„¢ by assessing solicited adverse events (AEs) in children living in a malaria-endemic area until 6 months after administration of the final dose of vaccine.
Timeframe: Day 0,1-6,28,29-34,98,99-104,126,127-132,154,155-160,182,183-188.
Safety: To assess the safety and reactogenicity of R78C, RH5.1 and R21 with Matrix-Mâ„¢ by assessing unsolicited adverse events (AEs) in children living in a malaria-endemic area until 6 months after administration of the final dose of vaccine.
Timeframe: Day 0,1-6,14,28,29-34,42,56,98,99-104,112,126,127-132,140,154,155-160,168,182,183-188,196.
Safety: To assess the safety and reactogenicity of R78C, RH5.1 and R21 with Matrix-Mâ„¢ by assessing serious adverse events (SAEs) in children living in a malaria-endemic area until 6 months after administration of the final dose of vaccine.
Timeframe: Throughout study completion, an average of 1 year