ACTRN12618002041235已完成1 期
A Randomized Double-Blind, Placebo Controlled, Phase I Study of the Safety, Tolerability, and Immunogenicity of a Live Attenuated H1N1 Vaccine in Healthy Individuals
Clincial Network Services (CNS) Pty Ltd0 个研究点目标入组 33 人开始时间: 2018年12月20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
- 33
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 45 Years（—）
- 性别
- All
入选标准
- •1. Adult volunteers, aged 18 to 45 years (at the time of screening).
- •a. In good general health in the opinion of the Medical Investigator or delegate, with no significant medical history and no clinically significant abnormal findings at screening. Participants with minor medical problems (for example, mild gastro-oesophageal reflux), which are unlikely to interfere with participant safety, the study procedures and/or results, and are not excluded elsewhere in the protocol, may be included at the discretion of the Medical Investigator. Furthermore, medications which are unlikely to interfere with participant safety, study procedures and/or results, and which are not excluded elsewhere in the protocol, may be permitted at the discretion of the Medical Investigator.
- •2. Participants must use highly effective, double contraception from the Screening Visit and up to the Follow-up Visit (Day 30). Double contraception is defined as a condom AND one other form of the following:
- •a. Established hormonal contraception (with approved oral, injected or depot regimen) for at least 2 months prior to screening
- •b. Depot or injectable birth control
- •c. Intrauterine device or intrauterine system in place for at least 2 months prior to screening
- •d. Documented evidence of surgical sterilization at least 6 months prior to Screening Visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men (with appropriate post-vasectomy documentation of the absence of sperm in semen) provided the male partner is a sole partner;
- •Males must not donate sperm for at least 70 days post-dose of the last study treatment. Male partners of female participants and female partners of male participants must also use contraception, if they are of childbearing potential. WOCBP must have a negative serum pregnancy test at Screening and Day 30. WNOCBP must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by FSH level meets the requirement of post-menopausal women if in doubt.
- •Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant abstinence for the duration of the study and 1 month after the last study treatment is acceptable.
- •3. Must be willing to comply with the following conditions to prevent the spread of GMOs according the Office of Gene Technology Regulator (OGTR) Licence (DIR 144):
- •a. Hygiene measures intended to prevent interpersonal transmission of study drug must be implemented, including but not limited to frequent handwashing with soap or hand disinfectant, respiratory hygiene and cough etiquette within 7 days following vaccination
- •b. Blood, tissue or organs must not be donated within 7 days of vaccination
- •c. Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days of vaccination
- •d. Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days of vaccination
- •e. All tissues and materials used to collect respiratory secretions are to be sealed in a primary container and placed within a secondary container so that it is not accessible to children or animals for 7 days until it is returned to the study site for disposal, for 7 days within vaccination
- •4. Contact is not to be made with infants <6 months of age within 7 days of vaccination
- •5. Adequate ven
排除标准
- •1. Immunodeficiency (including HIV) or autoimmune disorder, or participant is currently taking drugs (excluding steroids, see exclusion criteria 16) or was undergoing a form of treatment within 3 months prior to study entry that affects the immune system, or participant is living with somebody with the same.
- •2. Participant is not to have had Guillain-Barre Syndrome
- •3. Received blood or blood products in the 3 months prior to screening
- •4. Received another vaccine within 30 days before screening
- •5. Received another influenza vaccine from 2016 to present year
- •6. Participants with plans to travel to the Northern Hemisphere during the Screening period
- •7. Participated in another clinical study (involving an investigational product or device) within 60 days before screening
- •8. Suffered previous anaphylactic reaction to foods, vaccines, drugs or hymenoptera stings, or has a history of severe allergic reactions (e.g. clinically severe urticaria, asthma)
- •9. Participants with active asthma, or a history of childhood asthma which was treated with corticosteroids.
- •10. Participants with a known egg allergy
- •11. If female, pregnant, planning to become pregnant, or lactating, or participants is living with somebody who is pregnant or lactating
- •12. Participant has a history of, or current evidence at the time of screening of abuse of alcohol or any drug substance, licit or illicit, or current alcohol consumption is > 4 standard drinks (or equivalent) per day
- •13. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
- •14. Current or history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
- •15. Clinically significant abnormal laboratory value at screening as determined by the Investigator
- •16. Known or suspected impairment/alteration of immune function, including: Chronic use of oral steroids (equivalent to 20 mg/day prednisone equals 12 weeks /equals 2 mg/kg body weight / day prednisone equals 2 weeks) within 60 days prior to Day 0 (use of inhaled, IN, or topical corticosteroids is allowed, unless used for the management of asthma – see exclusion criteria 9). Receipt of parenteral steroids (equivalent to 20 mg/day prednisone equals 12 weeks /equals 2 mg/kg body weight/day prednisone equals 2 weeks) within 60 days prior to Day 0. Or participant is living with somebody with the same.
- •17. Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety parameters
- •18. Participant is seropositive to HCV or HBV
- •19. Body temperature (oral) equals 38.0 degrees Celsius or acute illness within 5 days prior to vaccination
- •20. Any other significant finding that, in the opinion of the Investigator, would increase the risk of the individual having an adverse outcome from participating in this study
- •21. Participant is a member of the team or is related or in a dependent relationship with a member of the study team, as defined as the Sponsor or study site personnel
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