Status:
COMPLETED
Study of Alternative Vaccination Schedule of Oral Cholera Vaccine
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Conditions:
Cholera
Diarrhoea
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to...
Detailed Description
Cholera is a re-emerging infectious disease that causes significant morbidity and mortality in populations lacking access to safe drinking water and sanitation. Provision of safe drinking water and fo...
Eligibility Criteria
Inclusion
- Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata.
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT01233362
Start Date
December 1 2010
End Date
February 1 2013
Last Update
September 25 2013
Active Locations (1)
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1
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India, 700010