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



Status:Completed
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 45
Updated:7/4/2018
Start Date:May 2014
End Date:June 2015

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Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Consistency Study in Healthy Adult Volunteers to Assess Immunogenicity, and Clinical Acceptability of a Single-dose of Live Oral Cholera Vaccine Candidate PXVX0200, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

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

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

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
We found this trial at
20
sites
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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Dallas, Texas 75010
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Kansas City, Missouri 64114
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Las Vegas, Nevada 89119
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Lenexa, Kansas 66219
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, Kentucky 40509
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Miami, Florida
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Mobile, Alabama 36608
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1156 Bowman Road
Mount Pleasant, South Carolina 29464
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Norman, Oklahoma 73069
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Phoenix, Arizona 85004
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Rochester, New York 14609
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Saint Louis, Missouri 63110
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West Palm Beach, Florida 33409
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