Phase 2a Study of RTS,SAS01E Malaria Vaccine Doses and Schedules in Healthy Children Aged 5 to 60 Months in a Malaria Area

What this Trial Is About

Researchers are studying the safety and immune response of different dosing schedules and reduced doses of the RTS,SAS01E malaria vaccine in healthy children aged 5 to 60 months living in areas where malaria is common. This Phase 2a open-label randomized study aims to find the best vaccination regimen to protect young children against malaria, a serious infectious disease. The study is sponsored by GlaxoSmithKline and targets healthy children who have completed routine immunizations. Participants are randomly assigned to receive three doses of the RTS,SAS01E vaccine on one of three schedules Day 1, Month 1, and Month 2 Day 1, Month 1, and Month 7 or Day 1, Month 2, and Month 7. The vaccine is given as an injection into the muscle. The study follows participants for up to 19 months to compare immune responses and safety across these different dosing schedules. During the study, children will have blood tests at multiple time points to measure antibodies against malaria and hepatitis B, along with monitoring for any side effects following vaccination. Researchers will track any adverse events, including serious ones, for up to 19 months after the first dose. Parents or guardians will complete diaries and attend follow-up visits to help monitor health and vaccine effects throughout the study period.

A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months