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A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa

NCT03855995 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77953

Last updated 2026-03-02

No results posted yet for this study

Summary

The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been introduced. Along with safety, researchers will also assess how well the vaccine works and its overall impact on children's health.

Conditions

Interventions

PROCEDURE

Whole blood sample

Whole blood samples will be collected from all enrolled children hospitalised and suspected of having an AESI or meningitis.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2025-08-07
Completion
2025-08-07

Countries

  • Ghana
  • Kenya
  • Malawi

Study Locations

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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 NCT03855995 on ClinicalTrials.gov