A clinical trial to see whether an alternate vaccination schedule of the killed oral cholera vaccine is as immunogenic as the standard vaccine schedule
- Registration Number
- CTRI/2010/091/002807
- Lead Sponsor
- International Vaccine InstituteSeoul Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 386
Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata.
All subjects must satisfy the following criteria at study entry:
1.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).
2.Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 ? 17 years.
3.Healthy subjects as determined by:
Medical history
Physical examination
Clinical judgment of the investigator
The following criteria should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study:
1.Ongoing serious chronic disease
2.For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
3.Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day)
4.Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment
5.One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
6.One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
7.Intake of any anti-diarrhea medicine in the past week
8.Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
9.Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC warrants deferral of the vaccination pending recovery of the subject
10.Receipt of immunoglobulin or any blood product during the past 3 months
11.Receipt of antibiotics in past 14 days
12.Receipt of live or killed enteric vaccine in past 4 weeks
13.Receipt of killed oral cholera vaccine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after last dose of study agent in each dose-interval groupTimepoint: Primary Time point is the measurement of serum vibriocidal titres,relative to baseline, 14 days after last dose of study agent in each dose-interval group
- Secondary Outcome Measures
Name Time Method