Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Observer Blinded, Controlled Trial to Evaluate the Safety and Immunogenicity of a New Formulation of Euvichol® (Killed Bivalent Whole Cell Oral Cholera Vaccine Manufactured by EuBiologics Co. Ltd.) in Healthy Individuals
Brief Summary: * Number of doses and intervals: Two doses, 2 weeks apart
* Method of administration: Oral administration
* Volume of vaccine to be administered: 1.5 mL/dose
* Observational period: 4 weeks (2 weeks after each dose)
* Number of visits: 3 visits

  1. Visit 1: Screening and enrollment (1st dosing)
  2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)
  3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This study will be carried out in healthy adults and children, at two sites, enrollment will be competitive between the sites. Subjects will be stratified according to age into adults (18\~40 years of age) and children (1\~17 years of age). According to the pre-generated randomization list, the participants will be randomized to the test or comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, blood sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the participants will be observed for 30 minutes post vaccination and instructed to record solicited adverse events that occur up to 6 days after vaccination on the participant diary card.

This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator will remain blinded and will not handle the investigational product.


Options:
A: Inclusion Criteria:

1. Age: 1-45 Years.
2. Informed consent from study participants and guardian in case of children (1-17 years) and assent from children aged 11-17 years.
3. Participation in the study at least for next 6 months
4. Considered healthy as per medical judgment of the investigator

Exclusion Criteria:

1. Suffering from diarrhea or abdominal pain or vomiting in the past 24 hours or diarrhea lasting for more than 2 weeks in the past 6 months
2. History of taking oral cholera vaccine and history of confirmed cholera.
3. History of taking any other live or killed enteric vaccine in the last 8 weeks.
4. History of anaphylaxis or serious vaccine reaction.
5. Currently use of any immunosuppressive or immune-modifying drugs. 6.100.4 0 F (38℃) or higher body temperature measured prior to investigational product dosing.

7.Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.

8.Currently on antimicrobial therapy. 9.Severe malnutrition or chornic disease based on the jugement of the investigator.

10.Stool sample at screening positive for V. cholerae. 11.Pregnant women or plans to become pregnant during the study period .
B: Inclusion Criteria:

* Healthy residents of selected vaccination sites
* Aged 2 years and older
* non-pregnant

Exclusion Criteria:

* Age less than 2 years
* Pregnant
C: Inclusion Criteria:

1. Apparently healthy residents of selected vaccination sites
2. Aged 1 year and above
3. Non-pregnant women
4. Written informed consent

Exclusion Criteria:

1. Age less than 1 year
2. Pregnant women
D: Inclusion Criteria:

1. Subject willing to provide written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
2. Individuals aged 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. Known history of hypersensitivity reactions to other preventive vaccines.
2. Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (\> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic drugs or other immunosuppressants.
3. 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 diarrhoea within 1 week prior to study initiation.
7. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
8. Other vaccination within 1 week prior to study initiation or planned vaccination during the study, except for tetanus toxoid vaccine.
9. Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
10. Pregnant or lactating women, women of reproductive age planning pregnancy and/or lactation before the end of the study period.
11. An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
12. History of cholera vaccinations or history of cholera.
13. History of alcohol or substance abuse
14. Participant planning to move from the study area before the end of study period.

Answer: D