A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

May 8, 2019

Study Completion Date

November 11, 2019

Conditions
Dysentery, Bacillary
Interventions
BIOLOGICAL

S.sonnei vaccine

Subjects receiving 2 doses of the study vaccine by intramuscular route, 28 days apart (at Day 1 and Day 29).

DRUG

Placebo

Subjects receiving 2 doses of placebo by intramuscular route, 28 days apart (at Day 1 and Day 29).

BIOLOGICAL

S. sonnei 53G challenge strain

Subjects receiving the challenge dose of S. sonnei 53G strain, orally, at Day 57.

Trial Locations (1)

45229

GSK Investigational Site, Cincinnati

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03527173 - A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults | Biotech Hunter | Biotech Hunter