A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Adults

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


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Double-blind, Placebo-Controlled Three-Lot Consistency Study in Healthy Adult Volunteers to Assess Immunogenicity, and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
Enrollment: 3146
Study Start Date: May 2014
Study Completion Date: June 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: PXVX0200
- Placebo Comparator: Placebo