Study of Alternative Vaccination Schedule of Oral Cholera Vaccine
Cholera, Diarrhoea, Vibrio Infection
About this trial
This is an interventional prevention trial for Cholera focused on measuring Cholera, Vaccine, Kolkata, West Bengal, India, Immunogenicity, Vaccination Schedules
Eligibility Criteria
Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata.
Inclusion Criteria:
- Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
- Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
Healthy subjects as determined by:
- Medical history
- Physical examination
- Clinical judgment of the investigator
Exclusion Criteria:
- Ongoing serious chronic disease
- For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
- Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day)
- Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment
- One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- Intake of any anti-diarrhea medicine in the past week
- Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC warrants deferral of the vaccination pending recovery of the subject
- Receipt of immunoglobulin or any blood product during the past 3 months
- Receipt of antibiotics in past 14 days
- Receipt of live or killed enteric vaccine in past 4 weeks
- Receipt of killed oral cholera vaccine
Sites / Locations
- National Institute of Cholera and Enteric Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm 1: Adults; 14 days interval
Arm 2: Adults; 28 days interval
Arm 3: children; 14 days interval
Arm 4: children; 28 days interval
Arm 5: Adults; 14 days Interval
Arm 6: Adults; 28 days interval
89 Adults (=> 18 years aged) receiving study agents (Vaccine/Placebo) at 14 days inter-dose interval
89 Adults (=> 18 years aged) receiving study agents (Vaccine/Placebo) at 28 days inter-dose interval
89 children (1-17 years aged) receiving study agents (Vaccine/Placebo) at 14 days inter-dose interval
89 children (1-17 years aged) receiving study agents (Vaccine/Placebo) at 28 days inter-dose interval
15 Adults (=> 18 years aged) receiving study agents (Vaccine/Placebo) at 14 days inter-dose interval
15 Adults (=> 18 years aged) receiving study agents (Vaccine/Placebo) at 28 days inter-dose interval