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

NCT06663436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-30

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
39 Weeks
Max Age
43 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-10-21
Completion
2025-10-21

Countries

  • Kenya

Study Locations

More Related Trials

Entities

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 NCT06663436 on ClinicalTrials.gov