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RECRUITING
NCT07036159
PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

5 Months - 60 Months

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2025-08-06

Completion Date

2027-04-23

Last Updated

2025-09-29

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

RTS,S/AS01E vaccine

RTS,S/AS01E vaccine will be administered intramuscularly.

Locations (2)

GSK Investigational Site

Kigali, Rwanda

GSK Investigational Site

Kigali, Rwanda