Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Observer Blinded Controlled Non Inferiority Trial to Evaluate the Safety and Immunogenicity of Locally Manufactured Inactivated Bivalent Whole Cell-oral Cholera Vaccine (WC-OCV) 'Cholvax' in Bangladeshi Healthy Adults and Children
Brief Summary: To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks.

Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).


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 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
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:

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

Answer: A