Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 30
- 主要终点
- Number of Participants with Unsolicited Adverse Events (AEs)
研究概览
简要总结
The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All participants will be unblinded at Day 29 (1 month following study injection) to seek immunization with licensed influenza and/or SARS-CoV-2 vaccines, outside of the study, per local standard of care.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Investigator assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
- •Body mass index of 18 to 35 kilograms/square meter (kg/m^2) (inclusive) at the Screening Visit(s).
- •For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.
- •Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. The most recent COVID-19 vaccine (primary series or booster) must be ≥120 days before (or less per local guidance) Day 1.
排除标准
- •Acutely ill or febrile (temperature ≥38.0°Celsius/[100.4°Fahrenheit]) 72 hours before or at the Screening Visit or Day
- •Participants meeting this criterion may be rescheduled within the 28-day screening window for re-evaluation and will retain their initially assigned participant number.
- •Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- •Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- •Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days before study injections (Day 1) or within 28 days after the study injection.
- •Received a licensed seasonal influenza vaccine or any other investigational influenza or RSV vaccine within ≤180 days before Day
- •Tested positive for influenza or RSV by local health authority-approved testing methods within ≤180 days before Day
- •Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the United States Center for Disease Control (CDC) or the European Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19 case or known history of SARS-CoV-2 infection within the past 90 days before Day
- •Donated ≥450 mL of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
mRNA-1230 Dose Level B
Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.
干预措施: mRNA-1230 (Biological)
mRNA-1010
Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
干预措施: mRNA-1010 (Biological)
mRNA-1045 Dose Level A
Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.
干预措施: mRNA-1045 (Biological)
mRNA-1230 Dose Level C
Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.
干预措施: mRNA-1230 (Biological)
mRNA-1230 Dose Level A
Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.
干预措施: mRNA-1230 (Biological)
mRNA-1045 Dose Level C
Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
干预措施: mRNA-1045 (Biological)
mRNA-1045 Dose Level B
Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.
干预措施: mRNA-1045 (Biological)
mRNA-1273.214
Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.
干预措施: mRNA-1273.214 (Biological)
mRNA-1345
Participants will receive a dose of mRNA-1345 by IM injection 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: Up to Day 29 (28 days post vaccination)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 8 (7 days post vaccination)
Number of Participants with AEs Leading to Discontinuation
时间窗: Day 1 through Day 361
Number of Participants with Medically-Attended AEs (MAAEs)
时间窗: Day 1 through Day 361
Number of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Day 1 through Day 361
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Day 1 through Day 361
次要结局
- Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29(Baseline (Day 1), Day 29)
- Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay(Baseline (Day 1) to Day 29)
- Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29(Baseline (Day 1), Day 29)
- SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)(Baseline (Day 1) to Day 29)
- RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay(Baseline (Day 1) to Day 29)
- Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29(Baseline (Day 1), Day 29)
- Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29(Baseline (Day 1), Day 29)
- Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29(Baseline (Day 1), Day 29)
- Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29(Baseline (Day 1), Day 29)