Brief Title
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Official Title
Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
Brief Summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Detailed Description
The primary goal of this Phase III study is to compare three lots for consistency of manufacture.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
Secondary Outcome
SVA Seroconversion at Day 11
Condition
Cholera
Intervention
PXVX0200 Lot A
Study Arms / Comparison Groups
PXVX0200 Lot A
Description: PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
3146
Start Date
May 2014
Completion Date
June 2015
Primary Completion Date
February 2015
Eligibility Criteria
Inclusion Criteria: - healthy men or women, - age 18 to 45 years inclusive; - normal medical history and physical examination - Women must have a negative pregnancy test. Exclusion Criteria: - travel to a cholera endemic area in the previous 5 years; - abnormal stool pattern or regular use of laxatives; - Currently active unstable or undiagnosed medical conditions - current or recent antibiotic use; - pregnancy or nursing; - Previously received a licensed or investigational cholera vaccine - History of cholera or enterotoxigenic E. coli infection - History of Guillain-Barré Syndrome - Received or plans to receive any other licensed vaccines, except for seasonal influenza - Recipient of bone marrow or solid organ transplant - Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years - Use of systemic chemotherapy in the previous 5 years prior to the study - any immunosuppressive medical condition
Gender
All
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
James McCarty, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02094586
Organization ID
PXVX-VC-200-004
Responsible Party
Sponsor
Study Sponsor
Emergent BioSolutions
Study Sponsor
James McCarty, MD, Study Director, Emergent Travel Health Inc.
Verification Date
June 2021