To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children

A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children

Inclusion criteria

• Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
• Age of 1 ~ 40 years
• An individual who can be followed up during the study period and is capable of complying with the study requirements.

Exclusion criteria

• History of hypersensitivity reactions to other preventative vaccinations.
• Immune function disorders including immunodeficiency diseases.
• An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
• 38℃ or higher body temperature measured prior to investigational product dosing.
• Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
• Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
• Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
• Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
• Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
• Pregnant or lactating women.
• An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
• Applicable to the Pivotal study only: history of cholera vaccinations or history of cholera.