Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines

Inclusion Criteria:

1. Male or female subjects aged ≥18 to ≤65 years.

2. General good health as established by medical history and physical examination.

3. Written informed consent.

4. Females of childbearing potential must agree to use an efficacious hormonal orbarrier method of birth control during the study (14 days before immunization to day 28 ± 3). Abstinence is acceptable.

5. Available for all visits scheduled in this study.

Exclusion Criteria:

1. Vaccination against typhoid fever or cholera within 5 years before dosing.

2. History of clinical typhoid fever or cholera.

3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior tostudy period or vaccination planned during it.

4. Current intake of antibiotics or end of antibiotic therapy <8 days before first IMPadministration.

5. Chronic (longer than 14 days) administration of immunosuppressants or otherimmunemodifying drugs within 6 months before the first dose of IMP; oralcorticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded;inhaled or topical steroids allowed.

6. Acute or chronic clinically significant gastrointestinal disease.

7. Any confirmed or suspected immunosuppressive or immunodeficient condition, includinghuman immunodeficiency virus (HIV) infection.

8. Pregnancy or lactation.

9. Acute disease at the time of enrolment (defined as the presence of a moderate orsevere illness with or without fever (fever defined as body temperature of ≥38 °C).

10. Alcohol or drug abuse.

11. Suspected non-compliance.

12. Use of any investigational drug or vaccine within 30 days preceding the first doseof study vaccine, or planned use during the study period.

13. Any clinically significant history of known or suspected anaphylaxis orhypersensitivity reaction based on the judgement of the investigator.

14. Employee at the investigational site or relative or spouse of the investigator.

15. Any other criteria which, in the investigator's opinion, would compromise theability of a subject to participate in the study, a subject's well-being, or theoutcome of the study.