PACTR201905764389804已完成1 期
A Phase 1 age descending placebo controlled clinical trial to examine the safety, tolerability, and immunogenicity of an oral inactivated ETEC Vaccine (ETVAX®) in healthy adults and children in Zambia.
Scandinavian Biopharma0 个研究点目标入组 246 人开始时间: 2019年4月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
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
- •Healthy male or non-pregnant female adults ages 18 to 45 years old and children =6 and =23 months old at the time of enrolment, all inclusive.
- •General good health as determined by the screening evaluation conducted 1-7 days before enrolment and vaccination.
- •Adult subjects or parents to children properly informed about the study, able to understand it and sign or thumbprint the informed consent form.
- •Subject, parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period.
- •Willing to comply with all stipulated study procedures.
排除标准
- •1.Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) 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 or designee precludes participation in the study.
- •3.Known or suspected impairment of immunological function based on medical history and physical examination.
- •4.Clinical evidence of active gastrointestinal illness and acute disease at the time of enrolment
- •5.Participation in a research study involving another investigational product (defined as receipt of investigational product) including 30 days before planned date of first vaccination.
- •6.History of receiving any other vaccine within 7 days before ETVAX® vaccination.
- •7.Antibiotic administered within 7days before ETVAX® vaccination.
- •8.History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature = 37.5 C ) on axillary measurement
- •9.Prior receipt of oral cholera vaccine (specifically Dukoral®) or any ETEC vaccine.
- •10.Prior receipt of a blood transfusion or blood products, including immunoglobulins.
- •11.Current use of iron or zinc supplements within the past 7 days;
- •12.Current use of antacids (H2 blockers, omeprazole, OTC agents) within the past 7 days
- •13.current use of immunosuppressive drug (e.g steroids) within the past 7 days.
- •14.Receipt of antimicrobial drugs for any reason within 7 days before vaccination
- •15.History of diarrhoea during the 7 days before vaccination
- •16.Acute disease at the time of enrolment or during the 3 days prior to enrolment
- •17.Participant’s or parents/guardians not being able to or unwilling to accept active follow-up by the study staff
- •18.History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
- •19.Medically significant malnutrition, defined as moderate or more severe malnutrition (BMI <18.5 kg/m2 for Cohort A, weight-for-height z-score < - 2.0 SD for Cohort B and C)
- •20.Any condition which in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
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