JPRN-jRCT2031210619已完成3 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Efficacy, Safety, Reactogenicity, and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Japanese Adults Aged 60 Years and Older, and Safety, Reactogenicity, and Immunogenicity of the Vaccine in Japanese Adults Aged 20 to 59 Years at High-risk of RSV Disease
akama Takahiro0 个研究点目标入组 2,180 人开始时间: 2022年2月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •For Participants in Cohort 1 only
- •- Must be greater than or equal to (>=60) years old on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study
- •- Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
- •- Participants may have underlying illnesses such as hypertension, congestive heart failure (CHF), Chronic obstructive pulmonary disease (COPD), type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable and medically controlled in the judgement of the investigator at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider
- •For Participants in Cohort 2 only
- •- Must be aged 20 to 59 years (inclusive) on the day of signing the ICF and expected to be available for the duration of the study
- •- Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening
- •- Participant may have other underlying illnesses as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider
排除标准
- •Exclusion Criteria:
- •- Has a serious clinically unstable condition like, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent or limit the protocol-specified assessments
- •- History of malignancy within 5 years before screening or revaccination not in the following categories:
- •a. participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator;
- •b. participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
- •- Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
- •- Has an acute illness (including acute respiratory illnesses) or body temperature of >=38.0 degree Celsius (C) (>=100.4 Fahrenheit [F ] within 24 hours prior to administration of study vaccine)
- •- Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
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