Status:
COMPLETED
Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
University of Helsinki
Conditions:
Vaccine-Preventable Diseases
Typhoid Fever
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06104345
Start Date
October 25 2023
End Date
June 26 2024
Last Update
December 5 2024
Active Locations (1)
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1
Meilahti Vaccine Research Center, Helsinki University Hospital
Helsinki, Finland, 00290