MedTrace Logo

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

NCT07036159 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

RTS,S/AS01E vaccine

RTS,S/AS01E vaccine will be administered intramuscularly.

Sponsors & Collaborators

Principal Investigators

  • Julien M Nyombayire, MD, MSc · Center for Family Health Research

  • Mossi Nzeyimana, MD · Rinda Ubuzima Gatenga Medicalized Health Center University of Rwanda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2027-04-23
Completion
2027-04-23

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07036159 on ClinicalTrials.gov