NCT04056117View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

596

Participants

Timeline

Start Date

September 2, 2019

Primary Completion Date

September 1, 2022

Study Completion Date

November 14, 2022

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

Trial Locations (2)

1357-20200

Kenya Medical Research Institute (KEMRI)/ United States Army Medical Research Directorate- Kenya (USAMRD-K), Kericho

230-80108

KEMRI-Centre Geographic Medical Research-COAST (KEMRI-CGMRC), Kilifi

Sponsors
All Listed Sponsors
collaborator

Kenya Medical Research Institute

OTHER

collaborator

KEMRI-Wellcome Trust Collaborative Research Program

OTHER

lead

LimmaTech Biologics AG

INDUSTRY