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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cholera

In brief

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

Key facts

Study ID

NCT02094586

Run by

Bavarian Nordic

People needed

3146

Starts

2014-05-01

Expected to finish

2015-06-01

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy men or women,
• age 18 to 45 years inclusive;
• normal medical history and physical examination
• Women must have a negative pregnancy test.

You may not qualify if…

• 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

Where it is running

• Coastal Clinical Research — Mobile, Alabama, United States
• Clinical Reseach Consortium Arizona — Phoenix, Arizona, United States
• Avail Clinical Research — DeLand, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Palm Beach Research — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Central Kentucky Research — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• Boston University — Boston, Massachusetts, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• St. Louis University — St Louis, Missouri, United States
• Clinical Research Consortium Las Vegas — Las Vegas, Nevada, United States
• Rochester Clinical Research — Rochester, New York, United States
• Lion Research — Norman, Oklahoma, United States
• Coastal Carolina Research — Mt. Pleasant, South Carolina, United States
• Research Across America — Dallas, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States
• QIMR Berghofer Medical Research Institiue — Herston, Queensland, Australia
• AUS Trials Pty Ltd — Sherwood, Queensland, Australia
• CMAX — Adelaide, South Australia, Australia
• Emeritis Research — Malvern East, Victoria, Australia
• Nucleus Network — Melbourne, Victoria, Australia
• Linear Clinical Research — Nedlands, Western Australia, Australia

Full record on ClinicalTrials.gov

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