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Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

NCT03276962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2024-05-21

Study results available
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Summary

The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.

Conditions

Interventions

BIOLOGICAL

RTS,S/AS01E (Full dose)

Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).

BIOLOGICAL

RTS,S/AS01E (1/5th dose)

Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).

BIOLOGICAL

Rabies vaccine

Participants will receive intramuscular injection of rabies vaccine (0.1 ml).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2019-11-04
Completion
2022-11-14

Countries

  • Ghana
  • Kenya

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 NCT03276962 on ClinicalTrials.gov