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PXVX0200 (CVD103-HgR) vs Shanchol in Mali

NCT02145377 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-09-26

No results posted yet for this study

Summary

To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline.

To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.

Conditions

  • Cholera

Interventions

BIOLOGICAL

PXVX0200 10E8

Oral dose of PXVX0200 10E8

BIOLOGICAL

PXVX0200 10E9

Oral dose of PXVX0200 10E9

BIOLOGICAL

Placebo

Oral dose of sodium bicarbonate buffer

BIOLOGICAL

Shanchol

Licensed comparator

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Milagritos D Tapia, MD · University of Maryland, College Park

  • Samba O Sow, MD, MS · Centre pour le Developpement des Vaccins - Mali

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Mali

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 NCT02145377 on ClinicalTrials.gov