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Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine

NCT03981952 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-03-11

No results posted yet for this study

Summary

This is a randomized, placebo-controlled dose-escalation study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.

Conditions

  • Risk Reduction

Interventions

BIOLOGICAL

Trivalent Invasive Salmonella Disease Vaccine (6.25 µg)

6.25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.

BIOLOGICAL

Trivalent Invasive Salmonella Disease Vaccine (12 µg)

12 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.

BIOLOGICAL

Trivalent Invasive Salmonella Disease Vaccine (25 µg)

25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.

BIOLOGICAL

Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C)

The highest, well-tolerated dose of the conjugate vaccine among Cohorts A-C is administered via one or two intramuscular injection(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).

OTHER

Placebo

0.5 mL of buffer and preservative is administered via one or two intramuscular injections(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2021-05-07
Completion
2021-05-07
FDA Drug
Yes

Countries

  • United States

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 NCT03981952 on ClinicalTrials.gov