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 ≥60 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36,814
- 试验地点
- 266
- 主要终点
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
研究概览
简要总结
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.
The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
详细描述
The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.
In the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.
In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
mRNA-1345 BD
Single injection of mRNA-1345 on BD Day 1.
干预措施: mRNA-1345 (Drug)
Placebo
Single injection of mRNA-1345 matching-placebo on Day 1.
干预措施: Placebo (Drug)
mRNA-1345
Single injection of mRNA-1345 on Day 1.
干预措施: mRNA-1345 (Drug)
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to 7 days after each injection
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to 28 days after each injection
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
时间窗: From 14 days postinjection up to 12 months postinjection
VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).
Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies
时间窗: BD Day 29
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal
时间窗: Up to BD Day 181
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms
时间窗: From 14 days postinjection up to 12 months postinjection
VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100\*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).
Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
时间窗: BD Day 29
次要结局
- GMT of Serum RSV Neutralizing Antibodies(Baseline through up to 24 months postinjection)
- Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies(Baseline through up to 24 months postinjection)
- GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)(Baseline, BD Day 1, Day 29 and Day 181)
- VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD(From 14 days postinjection up to 12 months postinjection)
- Proportion of Participants with ≥4-fold Increases in Antibody Titers from Baseline(Baseline through up to 24 months postinjection)
- Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose(BD Day 29)
- GMT of Serum RSV-A and RSV-B Neutralizing Antibodies(BD Day 1 and Day 181)
- VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)(From 14 days postinjection up to 12 months postinjection)
- Seroresponse Rate in RSV Neutralizing Antibodies(Baseline through up to 24 months postinjection)
- Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers(Baseline through up to 24 months postinjection)
- SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)(Baseline, BD Day 1, Day 29 and Day 181)