PACTR201202000354245尚未招募未知
A RANDOMIZED, DOUBLE-BLIND, CONTROLLED TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF KILLED BIVALENT (O1 AND O139) WHOLE-CELL BASED ORAL CHOLERA VACCINE (SHANCHOL®) IN HEALTHY INDIVIDUALS IN ETHIOPIA
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Year(s) 至 999 Year(s)（—）
- 性别
- All
入选标准
- •1. Male or female adults aged 18 years and
- •above; and children aged 1 -17 years who
- •is available for follow-up visits and
- •specimen collection.
- •a. The subject should be able to continue
- •in the study for the next 4 weeks
- •b. The subject (or parent/guardian)should
- •be willing to provide 3 blood samples
- •2. For females of reproductive age, non
- •pregnant (as determined by urine pregnancy
- •3.Written informed consent obtained from the
- •subjects or their parents/guardians, and
- •written assent obtained from children aged
- •12 ¿ 17 years.
- •4.Healthy subjects as determined by:
- •a.Medical history
- •b.Physical examination
- •c.Clinical judgment of the investigator
排除标准
- •1. Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
- •2. Ongoing acute illness.
- •3. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
- •4. Immunocompromising condition or on chronic systemic steroid therapy
- •5. Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
- •6. Intake of any anti-diarrhea medicine in the past week
- •7. Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
- •8. Temperature ¿38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
- •9. Previous hypersensitivity to formaldehyde.
- •10. Receipt of immunoglobulin or any blood product during the past 3 months
- •11. Receipt of oral cholera vaccine in the past three years
- •12. Any potential subject currently participating or who will participate within the next six months in another clinical trial
- •13. Positive screening urine pregnancy test for females greater than 12 years of age
研究者
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