A Phase 1, Randomized, Open-label Staggered Dose-escalation and Observer-blind Expansion Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Multicomponent Vaccine mRNA-1365 (Profile 2 [RSV and hMPV]) in Healthy Adults ≥60 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 20
- 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 objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.
- •Body mass index within the range 18.5 to 35 kg/m2 (inclusive).
排除标准
- •History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- •Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin >Grade 1, or platelets ≥Grade
- •History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
- •History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- •Participants with immune-mediated (autoimmune) conditions are generally excluded.
- •Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and/or hMPV were administered to participants alone, or as part of a combination vaccine, at any time in the past.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
mRNA-1345 (Profile 1)
Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1.
干预措施: mRNA-1345 (Profile 1) (Biological)
mRNA-1345 (Profile 3)
Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1.
干预措施: mRNA-1345 (Profile 3) (Biological)
mRNA-1365 (Profile 2) Dose Level 2
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1.
干预措施: mRNA-1365 (Profile 2) (Biological)
mRNA-1365 (Profile 2) Dose Level 1
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1.
干预措施: mRNA-1365 (Profile 2) (Biological)
mRNA-1365 (Profile 2) Dose Level 3
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1.
干预措施: mRNA-1365 (Profile 2) (Biological)
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
时间窗: Up to End of Study (EOS) (Day 181)
次要结局
- Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)(Day 29)
- Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)(Day 29)
- Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level(Day 29)