CTRI/2010/091/002807已完成2 期
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 Korea1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2010年11月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The study is a placebo controlled double blind,randomized trial aimed to see whether the killed oral cholera avccine (Shancol) that is available in India are more immunogenic if the dosing interval between the two doses are increased,as evident from earlier findings where it has been shown that there is higher immune response following first dose than after the second dose given at 2 weeks interval. For the main study the sample size is 356,aged 1-17 yeras and 18 yeras and above. Additional 30 volunteers will be recruited for exploration of alternate assays to see the immune response to this vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, non-pregnant adults aged 18 years and above and healthy children aged
- •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.
排除标准
- •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 enrollment5.One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months6.One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months7.Intake of any anti-diarrhea medicine in the past week8.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 subject10.Receipt of immunoglobulin or any blood product during the past 3 months 11.Receipt of antibiotics in past 14 days12.Receipt of live or killed enteric vaccine in past 4 weeks13.Receipt of killed oral cholera vaccine.
结局指标
主要结局
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
时间窗: Primary Time point is the measurement of serum vibriocidal titres,relative to baseline, 14 days after last dose of study agent in each dose-interval group
次要结局
- 1.Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after first dose of study agent 2.Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the study agent, in each dose-interval group.3.Proportion of subjects given 2 doses of study agent given 14 and 28 days apart with any of the following adverse events:a.Immediate reactions within 30 minutes after each doseb.Serious Adverse Events occurring throughout the trialc.Reactogenicity during three consecutive days following each dose: Headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, fever, loss of appetite, general ill feelingi.Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period.ii.Fever is defined as having an oral or tympanic temperature of ≥38o C(For Safety:a.Immediate reactions within 30 minutes after each doseb.Serious Adverse Events occurring throughout the trialc.Reactogenicity during three consecutive days following each dose:For immunogenicity:14 days after each dose of the study agent, in each dose-interval group)
研究者
研究点 (1)
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