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Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

NCT01895855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2023-06-28

Study results available
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Summary

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

Conditions

  • Cholera

Interventions

BIOLOGICAL

PXVX0200

Single dose; liquid suspension after reconstitution with buffer; 5x10\^8

BIOLOGICAL

placebo

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • James McCarty, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

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 NCT01895855 on ClinicalTrials.gov