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RecruitingPhase 2NCT07036159

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

A Phase 2a, Open Label, Randomized, Interventional Study to Assess the Safety and Immunogenicity of Alternative Vaccination Regimens and Reduced Antigen Doses of RTS,S/AS01E Vaccine in Healthy Children Aged 5-60 Months in a Malaria-endemic Area

Sponsor

GlaxoSmithKline

Enrollment

238 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Malaria

Summary

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.

Eligibility

Min Age: 5 MonthsMax Age: 60 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called RTS,S/AS01E vaccine for people with malaria. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 5 Months to 60 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRTS,S/AS01E vaccine

RTS,S/AS01E vaccine will be administered intramuscularly.

Locations(2)

GSK Investigational Site

Kigali, Rwanda

GSK Investigational Site

Kigali, Rwanda

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NCT07036159

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