Actively Recruiting
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
Led by GlaxoSmithKline · Updated on 2025-09-29
238
Participants Needed
2
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
CONDITIONS
Official 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 World Health Organization Expanded Programme on Immunization vaccinations or have received all required vaccinations at recruitment
- Parent or legal guardian can comply with study requirements, including follow-up visits and diary completion
- Written informed consent obtained from parent or legal guardian before study procedures
- Healthy as confirmed by medical history and clinical exam
- Negative for HIV, hepatitis B, and hepatitis C
- Hemoglobin level above 8 g/dL
- Born after at least 37 weeks of gestation
You will not qualify if you...
- Progressive, unstable, or uncontrolled clinical conditions
- History or suspicion of allergy to any vaccine component
- Immunosuppressive or immunodeficient conditions
- Conditions that contraindicate intramuscular vaccination or blood draws
- Behavioral, cognitive, or psychiatric disorders interfering with participation
- Recurrent or uncontrolled neurological disorders or seizures
- Undernutrition defined as WHO Z-score less than -2 standard deviations
- Major congenital defects or other clinical conditions posing extra risk
- Significant lung, heart, liver, or kidney abnormalities
- Use of long-acting immune-modifying drugs starting 3 months before or during study
- Prior receipt of any malaria vaccine
- Use of investigational or non-registered products (except study vaccine) 30 days before or during study
- Planned vaccines not foreseen by protocol or country schedule near study vaccinations, except flu or public health campaign vaccines
- Administration of immunoglobulins, blood products, or bone marrow transplant 3 months before or during study
- Chronic use of immunosuppressants over 14 days starting 3 months before or during study (except inhaled or topical steroids)
- Participation in another clinical study involving investigational or invasive interventions
- Immediate family or household members of study personnel
- Children in care
AI-Screening
AI-Powered Screening
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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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
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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