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

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

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