Testing of boosting capacity of Shancol, a killed whole cell oral cholera vaccine,in previously vaccinated children and adults .
- Registration Number
- CTRI/2012/04/002574
- Lead Sponsor
- International Vaccine Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 426
All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol• and satisfy the following criteria at study entry:
1.Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.
a.The subject should be able to continue in the study for the next 6 weeks
b.The subject (or parent/guardian) should be willing to provide 3 blood samples
2.Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 â?? 17 years.
3.Healthy subjects as determined by:
a.Medical history
b.Physical examination
c.Clinical judgment of the investigator
1. Individuals who are too weak to get out of bed to receive the vaccine;
2.Pregnant women (identified through verbal screening);
3.Those less than 6 years of age; and
4.Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol•India)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method