A OPEN LABELED CONTROLLED TRIAL TO EVALUATE THE IMMUNE RESPONSE OF A BOOSTING REGIMEN WITH SHANCHOLâ?¢ A KILLED WHOLE CELL ORAL CHOLERA VACCINE (WC-OCV), IN PREVIOUSLY IMMUNIZED CHILDREN AND ADULTS IN EASTERN KOLKATA, INDIA

International Vaccine Institute0 个研究点目标入组 426 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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)

发起方