NCT05547087已完成2 期
A Phase 2, Randomized, Double-Blind, Dose Finding Study to Describe the Immunogenicity, Safety and Tolerability of VN-0200 in Japanese Adults Aged 60-80 Years
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 6
- 主要终点
- Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
研究概览
简要总结
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy elderly aged >=60 and =<80 years (at the time of informed consent).
- •Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.
排除标准
- •Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
- •Serious acute illness.
- •Has been diagnosed with congenital or acquired immunodeficiency.
- •Previous vaccination with an RSV vaccine (including the investigational drugs).
- •Having a history of anaphylaxis or severe allergies due to medicines, or vaccination.
- •Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. * <14 days, 20 mg/day on a prednisolone basis.
- •Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination.
结局指标
主要结局
Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
时间窗: Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
时间窗: Day 57 (28 days after the second dosing of the investigational product)
次要结局
- Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity(Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product))
- Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)(Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product))
- Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)(Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product))
- Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity(Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product))
- Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity(Day 29 (the second dosing of the investigational product))
- Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity(Day 29 (the second dosing of the investigational product))
- Number of Participants Reporting Potential Immune-Mediated Disease(Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months))
- Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions(Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month)
- Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions(Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months)
- VAGA-9001a Specific IFN-Gamma Production Responses(Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product))
- Number of Participants Reporting Serious Adverse Events and Side Reactions(From date of informed consent up to approximately 12 months)
研究者
研究点 (6)
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