PACTR202010819218562尚未招募2 期
An individually-randomized, double-blind, placebo-controlled phase 2b trial (OEV-128) examining the efficacy of oral inactivated ETVAX vaccine to prevent enterotoxigenic E. coli-associated diarrhoea in Gambian children ages 6 to 18 months.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 4,936
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 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1.Healthy children 6 to 18 months old at the time of enrolment.
- •2.Generally good health over the 7 days before enrolment and the day of 1st dose of vaccine/placebo.
- •3.Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form.
- •4.Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period.
排除标准
- •1. Presence of any significant known systemic disorder as determined by medical history and/or physical examination which would endanger the participant’s health or is likely to result in non-conformance to the protocol.
- •2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination.
- •3. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrolment.
- •4. Participation in research involving another investigational product 30 days before planned date of first vaccination.
- •5. Receiving any other vaccines given within 7 days before ETVAX® vaccination.
- •6. Antibiotics administered within 7 days before ETVAX® vaccination.
- •7. Febrile illness within 48 hours prior to vaccination or documented fever at the time of immunization (fever is defined as a temp = 37.5°C)
- •8. Prior receipt of Dukoral, an oral cholera vaccine, or any ETEC vaccine.
- •9. Prior receipt of a blood transfusion or blood products, including immunoglobulins.
- •10. Current use of iron or zinc supplements within the past 7 days.
- •11. Current use of antacids (H2 blockers, omeprazole, over the counter agents or immunosuppressive drug within the past 7 days.
- •12. Any condition that in the opinion of the PI might jeopardize the safety of study participants or interfere with the evaluation of the study objectives.
- •13. Diarrhoea during 7 days before vaccination.
- •14. Acute disease at the time of enrolment or during the 3 days prior to enrolment.
- •15. Participant’s parents not able, available or willing to accept active follow-up by the study staff.
- •16. History of chronic administration (defined as more than 14 days) of immunosuppressants
- •17. Malnutrition (wt-for-ht z-score <-2.0)
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