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A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants

NCT04056117 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2024-07-30

No results posted yet for this study

Summary

In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old infants.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Shigella 4V

Non-adjuvanted and adjuvanted Shigella 4V administrated at 4 different doses: very low, low, medium and high.

BIOLOGICAL

MenACWY

Control vaccine administrated to adults and infants

BIOLOGICAL

Rabies

Control vaccine administrated to children

BIOLOGICAL

Diphtheria, Tetanus and Pertussis (DTaP)

Control vaccine administrated to infants

BIOLOGICAL

Placebo

Control administrated to adults

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Mainga Hamaluba, MD · KEMRI/Welcome Trust Research Programme,Kilifi, Kenya

  • Josphat Kosgei, MD · Medical Research Institute, Kericho, Kenya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2022-09-01
Completion
2022-11-14

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Drugs

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 NCT04056117 on ClinicalTrials.gov