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A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

NCT02094586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3146

Last updated 2023-06-28

Study results available
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Summary

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Conditions

  • Cholera

Interventions

BIOLOGICAL

PXVX0200 Lot A

Lot P700-1CA03

BIOLOGICAL

PXVX0200 Lot B

Lot P700-3CA03

BIOLOGICAL

PXVX0200 Lot C

Lot P700-6BA03

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • James McCarty, MD · Emergent Travel Health Inc.

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
2014-05-31
Primary Completion
2015-02-28
Completion
2015-06-30

Countries

  • United States
  • Australia

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 NCT02094586 on ClinicalTrials.gov