Salmonella Conjugates CVD 2000: Study of Responses to Vaccination With Trivalent Salmonella Conjugate Vaccine to Prevent Invasive Salmonella Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

August 15, 2022

Primary Completion Date

June 12, 2023

Study Completion Date

June 12, 2023

Conditions
Risk Reduction
Interventions
BIOLOGICAL

Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation

One dose of the full-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The full-strength conjugate vaccine consists of 25 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi.

BIOLOGICAL

Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation

One dose of the half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The half-strength conjugate vaccine consists of 12.5 mcg of Salmonella Enteritidis, 12.5 mg of Salmonella Typhimurium, and 25 mcg of Salmonella Typhi Vi.

BIOLOGICAL

Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation

One dose of the dilutional half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The dilutional half-strength conjugate vaccine consists of 12.5 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi.

OTHER

Placebo

One dose of placebo is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The placebo consists of sterile phosphate-buffered saline (PBS) solution containing polysorbate 80, and 2-phenoxyethanol preservative.

Trial Locations (1)

21201

Pharmaron, Baltimore

All Listed Sponsors
lead

University of Maryland, Baltimore

OTHER