Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine (NCT01508507) | Clinical Trial Compass
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Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine
India240 participantsStarted 2013-03
Plain-language summary
Various field studies has found that the modified , bivalent, whole cell - based oral cholera vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in earlier clinical trials. However, the effectiveness of the vaccine in "real" life situation using the public health system is unknown. It is critical to follow up in the same population, where pilot introduction of OCV was introduced and evaluate vaccine proactive effectiveness at individual as well as at population level. The follow - up and determination of effectiveness of mass OCV vaccination was requested by State Government.
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.
Inclusion criteria for cases of the main case-control study are as follows:
* Giving verbal informed consent/assent, or in the case of minors, a parent or guardian give informed consent to participate in the study
* Living in the study area since the start of the mass vaccination
* Submitted a faecal specimen
* Whose residence could be located
* Whose stool specimens yield V. cholera O1 or O139
* Belonging to study population through census database
Exclusion criteria:
* Not giving verbal informed consent/assent, or in the case of minors, a parent or guardian does not give informed consent to participate in the study
* Not living in the study area since the start of the mass vaccination
* No faecal specimen
* Whose residence could not be located
* Whose stool specimens does not yield V. cholera O1 or O139
* Not belonging to study population through census database
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
Vaccine protective effectiveness at individual level