Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children

Exclusion Criteria18

• Known history or allergy to investigational vaccine components or other medications, or any other allergies
• Individuals with major congenital abnormalities
• Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)
• Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.
• Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
• Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial
• Individuals with splenectomy
• Individuals with known bleeding disorders
• Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months
• Individuals who have received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the investigational product.
• Individuals with active or known previous Vibrio cholerae infection
• Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more
• Individuals with prior receipt of a cholera vaccine in the last 5 years
• Any female participant who is lactating or pregnant
• Females of childbearing potential who do not agree to use an effective birth control method for at least 4 weeks before the screening and up to 12 weeks after the study vaccination.
• Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period
• Individuals who are research staff involved with the clinical trial or family/household members of research staff
• Children below 5 years old with Weight for Height Z score and/or Height for Age Z score of less than -2