Immunogenicity and safety of the Japanese encephalitis vaccine given intradermally in children and adults
- Conditions
- Japanese encephalitisInfection - Other infectious diseasesInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12623000214639
- Lead Sponsor
- Sydney Children's Hospital Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 900
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.
OR
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method