NCT06663436

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants

A Phase 2 Single-Blind, Randomized, Controlled, Single Center Study to Assess the Immunogenicity and Safety of a 2-Dose Schedule With GVGH altsonflex1-2-3 Vaccine in African Infants (H06_02TP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 39 Weeks – 43 Weeks
• Healthy volunteers: Accepted

Summary

This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric population) clinical study in Kenya, with the aim of identifying a preferred dose, using a 3-dose vaccination schedule in infants from 9 months of age (NCT05073003). This Phase 2 clinical study will evaluate the safety and immunogenicity of an alternative 2-dose vaccination schedule.

Conditions

• Diarrhoea

Interventions

Type	Name	Description
BIOLOGICAL	altSonflex1-2-3 Dose A	altSonflex1-2-3 Dose A administered intramuscularly on Day 1 and Day 169
BIOLOGICAL	altSonflex1-2-3 Dose B	altSonflex1-2-3 Dose B administered intramuscularly on Day 1 and Day 169
BIOLOGICAL	altSonflex1-2-3 Dose C	altSonflex1-2-3 Dose C administered intramuscularly on Day 1 and Day 169
BIOLOGICAL	TYPHIBEV	TYPHIBEV administered intramuscularly on Day 1
COMBINATION_PRODUCT	Infanrix hexa	Infanrix hexa administered intramuscularly on Day 169
BIOLOGICAL	MR-VAC	MR-VAC co-administered subcutaneously on Day 1 and Day 169

Timeline

• Start date: 2024-11-13
• Primary completion: 2025-10-21
• Completion: 2025-10-21
• First posted: 2024-10-29
• Last updated: 2026-01-30

Locations

1 site across 1 country: Kenya