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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.

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

Official Title
-----------------
A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children

Conditions
-----------------
Prevention Harmful Effects

Intervention / Treatment
-----------------
* Biological: Euvichol
* Biological: Shanchol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Euvichol<br>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 | Biological: Euvichol<br>* 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<br>* Other names: Oral Cholerae Vaccine;|
| Active Comparator: Shanchol<br>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 | Biological: Shanchol<br>* 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<br>* Other names: Oral cholera vaccine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline | 14 days after second doses | 
| Safety | Type and frequency of solicited adverse event type (Day 0   6), Type and frequency of unsolicited adverse event type (Day 0   Day 28) | From first shot to 14 days after second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 1. Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline | 14 days after second doses | 
| Safety | 1. Change from baseline in vital signs and physical examination | From first shot to 14 days after second dose | 
| Efficacy | 1. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by each anti-V. cholera antibody titer at Week 2 (Visit 3) after the second dose as compared to prior to investigational product dosing (Visit 1). | 14 days after second doses | 
| Safety | 1. Change from baseline in laboratory tests (hematologic test, blood chemistry test, urinalysis) to be performed only in subjects who participate in the Pivotal study. | 14 days after second doses |