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

Inclusion criteria

• Male or female subjects aged ≥18 to ≤65 years.
• General good health as established by medical history and physical examination.
• Written informed consent.
• Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study (14 days before immunization to day 28 ± 3). Abstinence is acceptable.
• Available for all visits scheduled in this study.

Exclusion criteria

• Vaccination against typhoid fever or cholera within 5 years before dosing.
• History of clinical typhoid fever or cholera.
• Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
• Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration.
• Chronic (longer than 14 days) administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids allowed.
• Acute or chronic clinically significant gastrointestinal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Pregnancy or lactation.
• Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever (fever defined as body temperature of ≥38 °C).
• Alcohol or drug abuse.
• Suspected non-compliance.
• Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator.
• Employee at the investigational site or relative or spouse of the investigator.
• Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study.