A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE IMMUNOGENICITY OF TWO DOSES OF THE MODIFIED KILLED WHOLE CELL ORAL CHOLERA VACCINE (WC-OCV) UNDER TWO ALTERNATIVE VACCINATION SCHEDULES

International Vaccine InstituteSeoul Korea0 个研究点目标入组 386 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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•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

发起方

International Vaccine InstituteSeoul Korea