CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,500 enrolled
Drug / intervention
RTS,S/AS01E (Full dose) +2 morebiological
Likely dose
RTS,S/AS01E (Full dose) 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03276962
NCT03276962Phase 2Completed
CompareCT.gov

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

GlaxoSmithKline·interventional·Posted Sep 8, 2017·Updated May 21, 2024

In Brief

A Phase 2 clinical trial evaluating RTS,S/AS01E (Full dose), RTS,S/AS01E (1/5th dose), and 1 other intervention for Malaria. Completed, enrolled 1,500 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesGhana, Kenya
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 8, 2017
Enrollment StartSep 28, 2017
Primary CompletionNov 4, 2019
Study CompletionNov 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.8 years ago

Interventions

RTS,S/AS01E (Full dose)biological

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

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

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

Rabies vaccinebiological

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