ACTRN12623000925640进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Reactogenicity and Immunogenicity of MYNFLU001 Cell Derived, Adjuvanted, Quadrivalent Influenza Vaccine in Healthy Adults
Mynvax Pty. Ltd.0 个研究点目标入组 46 人开始时间: 2023年8月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- 18 Years 至 59 Years（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent.
- •2. Healthy participants as established by medical history, laboratory examination, physical examination and vital signs during screening and as per the clinical judgment of the investigator.
- •3. Body Mass Index (BMI) within the range 18 to 35 kg/m2 (inclusive)
- •4. Women of childbearing potential must have a negative urine pregnancy test at Screening and pre-dose on Day 1, and must agree to remain sexually abstinent, use medically effective contraception, or have a partner who is sterile or same-sex, from Screening until at least 90 days after the 2nd vaccination. Females with natural amenorrhea for <2 years (without an alternative medical cause) and who are not surgically sterile, i.e. tubal ligation, bilateral oophorectomy, or complete hysterectomy will only be considered not to be of childbearing potential if they have a documented follicle- stimulating hormone (FSH) value in the postmenopausal range.
- •5. Sexually active male participants who are considered sexually fertile must agree to use either a barrier method of contraception from the time of 1st vaccination until at least 90 days after the 2nd vaccination, or have a same-sex partner, or have a partner who is permanently sterile or unable to become pregnant;
- •6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Receipt of Inactivated Influenza Vaccine in the past 3 months
- •2. Fever (oral temperature greater than or equal to 37.5ºC) or any other respiratory symptoms/illnesses within 3 days of vaccine administration
- •3. Current active viral or bacterial infection
- •4. Individuals with history of any major pulmonary, cardiovascular, renal, neurological,
- •metabolic, gastrointestinal, hepato-biliary, blood dyscrasia, uncontrolled hypertension and
- •diabetes, clinically significant chronic pulmonary disease, asthma, or any condition which in
- •the opinion of the Investigator might interfere with the evaluation of the study objectives
- •5. Pregnant or lactating women or willingness/intention to become pregnant during the study
- •6. Women of child-bearing potential not agreeing to use adequate contraception during the study.
- •7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection
- •8. Severely immunocompromised participants. This exclusion category comprises a) participants with known infection by the human immunodeficiency virus (HIV); b) participants with solid organ transplantation; c) participants with bone marrow transplantation; d) participants under chemotherapy/radiotherapy; e) participants with primary immunodeficiency; g) treatment with any anti-cytokine therapies. h) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisolone or equivalent for longer than 3 months from the time of screening, or probable use of oral or intravenous steroids in the following four weeks
- •9. Receipt of blood/plasma products or immunoglobulin, within 60 days before study intervention administration or any planned receipt during the study duration
- •10. History of solid or non-solid malignancy or lymphoma (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •11. Personal or family history of Guillain-Barré syndrome
- •12. History of allergy or serious adverse reactions to the vaccine components, such as urticaria, dyspnoea, and angioedema
- •13. Known infection with hepatitis C virus (HCV), or hepatitis B virus (HBV)
- •14. Clinically significant abnormal laboratory finding on screening hematology and clinical chemistry
- •15. Eczema or other significant skin lesion or infection at the site/s of injection
- •16. Receipt of any non-Influenza vaccine or planned receipt of any non-Influenza vaccine within the period of study enrolment to 4 weeks after the second study vaccination dose.
- •17. Prior receipt of any investigational drugs or non-Influenza vaccines = 30 days before enrolment
- •18. Any other medical condition, including moderate or severe acute infection on the day of
- •vaccination which in the opinion of the Investigator may affect the participant’s safety or study participation and conduct.
研究者
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