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Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.

NCT06523231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-09

No results posted yet for this study

Summary

In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Shigella4V2

Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.

BIOLOGICAL

MenACWY

Control vaccine

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Richard Omore, PhD · KEMRI - Center for Global Health Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2025-08-27
Completion
2026-01-22

Countries

  • Kenya

Study Locations

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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 NCT06523231 on ClinicalTrials.gov