Actively Recruiting
A Phase 2a, Open Label, Randomized Study to Assess Safety and Immune Response of RTS,S/AS01E Malaria Vaccine in Healthy Children Aged 5-60 Months in Malaria-Endemic Area
Led by GlaxoSmithKline · Updated on 2025-09-29
238
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and immune response of different dosing schedules and reduced doses of the RTS,S/AS01E 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,S/AS01E 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.
CONDITIONS
Brief Title
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female children aged 5 to 60 months at first vaccination
- Completed WHO Expanded Programme on Immunization vaccinations or required local vaccinations at recruitment
- Parent or legal representative is able and willing to follow study requirements
- Written informed consent obtained from parent or legal representative
- Negative for HIV, hepatitis B, and hepatitis C infections
- Hemoglobin level greater than 8 g/dL
- Born after at least 37 weeks of gestation
You will not qualify if you...
- Progressive, unstable, or uncontrolled medical conditions
- History or suspicion of allergic reaction to any vaccine component
- Immunosuppressive or immunodeficient conditions
- Medical reasons preventing intramuscular vaccination or blood draws
- Behavioral, cognitive, or psychiatric conditions interfering with study participation
- Uncontrolled neurological disorders or seizures
- Undernutrition defined as WHO Z-score less than -2 SD
- Major congenital defects or other conditions posing additional risk
- Significant lung, heart, liver, or kidney abnormalities
- Use of long-acting immune-modifying drugs within 3 months prior or planned during study
- Prior receipt of any malaria vaccine
- Use of investigational or non-registered products within 30 days prior or planned during study
- Planned vaccination outside study protocol or routine immunization within restricted time windows
- Recent administration of blood products or bone marrow transplant
- Chronic use of immunosuppressants exceeding 14 days within 3 months prior or planned during study
- Participation in other clinical studies with investigational interventions
- Immediate family or household members of study personnel
- Child is in care (legal guardianship)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 months
Participants receive 3 doses of the RTS,S/AS01E malaria vaccine on different schedules depending on the group assignment.
3 vaccination visits plus follow-up visits up to Month 8
Duration - Up to 12 months after last vaccine dose
Participants are monitored for safety and immune response for up to 12 months after the last vaccine dose.
Periodic visits up to Month 19 depending on group
Trial Site Locations
Total: 2 locations
1
GSK Investigational Site
Kigali, Rwanda
Actively Recruiting
2
GSK Investigational Site
Kigali, Rwanda
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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