Status:
COMPLETED
Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Conditions:
Cholera
Diarrhea
Eligibility:
All Genders
1-40 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.
Detailed Description
Cholera is an important public health problem worldwide, particularly in endemic areas of the developing world. In 2004, 101 383 cholera cases and 2345 deaths were reported to the WHO. Provision of sa...
Eligibility Criteria
Inclusion
- Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years
- All subjects must satisfy the following criteria at study entry:
- Male or female adult residents aged 18-40 years or 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)
- For females of reproductive age, they must not be pregnant (as determined by verbal screening)
- Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
- Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.
Exclusion
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Diarrhea (3 or more loose 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-diarrhoeal 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 \> or = 38 degrees C (oral) or axillary temperature \> or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject
- receipt of antibiotics in past 14 days
- receipt of live or killed enteric vaccine in last month
- receipt of killed oral cholear vaccine
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00419133
Start Date
June 1 2007
End Date
August 1 2007
Last Update
December 7 2009
Active Locations (1)
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1
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India, 700010