Study of Alternative Vaccination Schedule of Oral Cholera Vaccine (NCT01233362) | Clinical Trial Compass
CompletedPhase 2
Study of Alternative Vaccination Schedule of Oral Cholera Vaccine
India386 participantsStarted 2010-12
Plain-language 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 observe a boost in the immune response. This study will compare the immune responses following 14-day and 28-day dosing intervals.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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 group
Timeframe: 14 days after the last dose of the study agent