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COMPLETED
NCT06663436
PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

39 Weeks - 43 Weeks

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-11-13

Completion Date

2025-10-21

Last Updated

2026-10-26

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

GSK Investigational Site

Kericho, Kenya