A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults over 60 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 主要终点
- Safety Endpoint: Solicited local and systemic adverse reactions (ARs)
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 60age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adults over 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (specifically chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable as assessed by the following criteria: absence of changes in medical therapy within 1 month due to treatment failure or toxicity; absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1; and absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely.
- •Body mass index from over18 kilograms(kg)/square meter (m2) to under 35 kg/m2.
排除标准
- •Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
- •Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
- •History of a serious reaction to any prior vaccination or Guillain-Barre syndrome within 6 weeks of any prior influenza immunization.
- •Received or plans to receive any nonstudy vaccine (including authorized or approved vaccines for the prevention of COVID-19 regardless of type of vaccine) within 28 days before or after the Day 1 study injection. Nonstudy vaccination(s) should not be delayed.
结局指标
主要结局
Safety Endpoint: Solicited local and systemic adverse reactions (ARs)
时间窗: up to 7 days postinjection
Numbers and percentages of participants with solicited local and systemic adverse reactions (ARs)
Safety Endpoint: Unsolicited adverse events (AEs)
时间窗: up to 28 days postinjection
Number of participants with unsolicited adverse events (AEs)
Safety Endpoint: Medically attended adverse events (MAAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and AEs leading to withdrawal
时间窗: up to 24 months postinjection
Number of participants with medically attended adverse events (MAAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and AEs leading to withdrawal
Efficacy Endpoint: Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD
时间窗: within the period of 14 days postinjection up to 12 months postinjection
Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD
次要结局
未报告次要终点