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Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine

NCT04349553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-08-17

Study results available
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Summary

A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.

Conditions

  • Enteric Fever

Interventions

BIOLOGICAL

ZH9PA and ZH9

150mL vaccine for oral administration

BIOLOGICAL

Placebo

150mL vaccine for oral administration

BIOLOGICAL

ZH9PA

150mL vaccine for oral administration

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Prokarium Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-09-28
Completion
2021-02-15

Countries

  • United Kingdom

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 NCT04349553 on ClinicalTrials.gov