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

EuBiologics

Status and phase: Completed; Phase 3

Conditions: Prevention Harmful Effects

Treatments: Biological: Euvichol; Biological: Shanchol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02164110

UBC301

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.

Full description

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

Enrollment: 3,632 patients

Sex: All

Ages: 1 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. History of hypersensitivity reactions to other preventative vaccinations.
2. Immune function disorders including immunodeficiency diseases.
3. An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
4. 38℃ or higher body temperature measured prior to investigational product dosing.
5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
6. Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
7. Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
9. Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
10. Pregnant or lactating women.
11. An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
12. Applicable to the Pivotal study only: history of cholera vaccinations or history of cholera.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,632 participants in 2 patient groups

Euvichol

Experimental group

Description:

* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose

Treatment:

Biological: Euvichol

Shanchol

Active Comparator group

Description:

* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose

Treatment:

Biological: Shanchol