A Phase 3 Open-label Study to Evaluate Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 at Least 12 Months Following a Primary Dose of a Licensed Protein Subunit RSV Vaccine in Adult Participants ≥60 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 11
- 主要终点
- Number of Participants with Unsolicited Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
- •Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity.
- •Absence of serious or significant medical events within 30 days of Visit
- •Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
- •Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit
- •Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.
排除标准
- •Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed.
- •Prior participation in research involving receipt of any investigational RSV product (drug/biologic).
- •Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study.
- •Other protocol-specified inclusion and/or exclusion criteria may apply.
研究组 & 干预措施
mRNA-1345
Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1.
干预措施: mRNA-1345 (Biological)
结局指标
主要结局
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Day 1 up to Day 28 (28 days post-injection)
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
时间窗: Day 1 up to Day 181 (End of study)
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29
时间窗: Day 29
GMT of Serum RSV-B Neutralizing Abs at Day 29
时间窗: Day 29
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Day 1 up to Day 7 (7 days post-injection)
次要结局
- Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers(Day 181)
- Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers(Day 181)
- GMT of Serum RSV-B Neutralizing Abs(Day 1 up to Day 181 (End of study))
- GMFR of Serum RSV-B Neutralizing Abs(Day 181)
- Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs(Day 181)
- Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs(Day 181)
- GMT of Serum RSV-A Neutralizing Abs(Day 1 up to Day 181 (End of study))
- Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs(Day 181)