Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Individually Randomized, Placebo-controlled Trial to Measure the Protection Conferred by a Single Dose Regimen of Bivalent, Killed, Whole Cell Oral Cholera Vaccine (Shanchol™) in Dhaka, Bangladesh
Brief Summary: Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional epidemics seen during times of floods, cyclones or any natural disaster. It affects all age groups with the majority of fatal cases occurring in children . Therefore, immunization against cholera remains an important public health component in the prevention and control of the disease .The current two-dose regimen of the internationally available oral cholera vaccines (OCV) create a logistical and programmatic challenge for use in national programs or during epidemics ,so it is important to determine if a single dose vaccine will be protective in regions where cholera is endemic. If the vaccine is found to be efficacious following a single dose, this will have profound implications for the use of the vaccine in areas with limited resources particularly in complex emergencies where a multiple dose regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability' and allow the vaccine to be used for outbreak control, especially in difficult settings where the risk of cholera is extremely high and provisions for clean water and sanitation are not available. With low OCV production rates, larger populations could be immunized against cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate the inclusion of a global stockpile strategy.

The study design is a two-arm individually randomized double-blind placebo-controlled trial. The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study treatment centres from 7 days to 6 months after dosage and whose identity is confirmed through home visit.


Options:
A: Inclusion Criteria:

* All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1 year of age of the study area

Exclusion Criteria:

* individuals who are too weak to get out of bed to receive the vaccine;
* pregnant women (identified through verbal screening); and
* those less than 1 year of age
B: Inclusion Criteria:

Healthy subjects \> 1 year of age and above Living in high risk area for cholera Provision of Informed consent for participating in the study by participant /parent or guardian as well as verbal assent for children 11-17 years.

Exclusion Criteria:

Pregnant women Aged less than 1 year History of taking cholera vaccine
C: Inclusion Criteria:

* Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years

Exclusion Criteria:

* Diarrhea during the past week
* Antibiotic and anti-diarrheal medicine use during the past week
* One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
* Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
* Pregnancy
D: 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 .

Answer: B