ACTRN12623000214639招募中3 期
Japanese encephalitis vaccine via intradermal route in children and adults (JEVID-2): A clinical trial comparing the immunogenicity and safety of Japanese encephalitis vaccine administered by subcutaneous and intradermal routes
Sydney Children's Hospital Network0 个研究点目标入组 900 人开始时间: 2023年2月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 5 Years 至 o limit（—）
- 性别
- All
入选标准
- •Potential participants must fulfil all of the following inclusion criteria to be eligible to participate in the study:
- •- Participants aged 5 years or older at the time of consent.
- •- For participants aged 5 to less than 18 years: Parents/ guardians willing and capable of providing written informed consent prior to the performance of any study-specific procedure.
- •For participants aged greater than or equal to 18 years: Willing and capable of providing written informed consent prior to the performance of any study-specific procedure
- •- The participant must be in good health as determined by the investigator and/or study nurse, as established by pertinent medical history, physical examination and vital signs assessments performed at Screening.
- •- The participant and parent must be able to attend all scheduled visits and to understand and comply with planned study procedures, in the Investigator’s judgement.
- •- Participant must not meet jurisdictional health department recommendation for JE vaccine to be given SC
排除标准
- •If any of the following exclusion criteria apply, the potential participant will not be able to participate in the study:
- •- Participant meets jurisdictional health department recommendation for JE vaccine to be given SC
- •- Known to previously have had JE disease
- •- Known to have lived in a JE endemic area outside Australia for greater than6 months
- •- Previously vaccinated with Imojev® or another JE vaccine
- •- Participant has a contraindication to JE vaccines
- •oanaphylaxis after a previous dose of any JE vaccine
- •oanaphylaxis after any component of a JE vaccine
- •- Previously vaccinated with dengue or yellow fever vaccines, or planning to have these vaccines during the first two months after receipt of the JE vaccine
- •- A history of dengue fever
- •- Pregnant women or planning pregnancy
- •- Breastfeeding or planning to breastfeed
- •- Participant receiving immunosuppressive medication or has medical condition(s) that impaired the normal functioning of the immune system (definitions as per the Australian Immunisation Handbook)
- •- History of any major (per Investigator’s discretion) cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, immunological and autoimmune diseases or any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- •- Chronic use (more than 14 continuous days) of any dose of systemic corticosteroids within 30 days prior to Screening. Intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted.
- •- Have (or have a family member who has) had a severe reaction to a live attenuated viral vaccine, or are related to someone with known IFNAR1 deficiency
- •- Have had a severe reaction to the MMR vaccine
- •- History of known or suspected hypersensitivity or any severe allergic reaction including anaphylaxis, generalised urticaria, angioedema, and other significant reaction to Imojev® vaccine or any vaccine component).
- •- Presence of active viral or bacterial infection, with or without fever (oral temperature greater than or equal to 37.8C) at Screening or within 72 hours prior to vaccination, if determined by the Investigator to be of clinical significance (enrolment may be delayed for full recovery if acceptable to the Investigator).
- •- Participating in any other clinical study and have received any other investigational product (i.e. study vaccine, drug, biologic or device) within 30 days or 5 half-lives (whichever is longer) prior to Screening, or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
- •- Received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination
- •- Received immunoglobulins and/or any blood or blood products within 3 months before vaccination or plans to receive any blood or blood products at any time during the study.
- •- Has any psychiatric or cognitive disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
研究者
相似试验
已完成
不适用
Seroconversion with Japanese encephalitis vaccine via intradermal route in healthy individualsACTRN12621000024842The University of Queensland51
已完成
3 期
Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese ToddlersJapanese EncephalitisMeaslesRubellaMumpsNCT01188343Sanofi Pasteur, a Sanofi Company542
已完成
1 期
Dose response study using microneedle array containing Japanese encephalitis vaccineJPRN-jRCTs011190004Hiroaki Iwata39
已完成
3 期
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51Japanese EncephalitisNCT00605085Valneva Austria GmbH2,675
尚未招募
3 期
ong Term Immunogenicity of the JE Vaccine IC51Prophylactic Vaccine against Japanese EncephalitisNeurological - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)ACTRN12605000681651Intercell AG600