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 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