A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,050
- 试验地点
- 70
- 主要终点
- Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
研究概览
简要总结
The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
- •Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:
- •Is a person of nonchildbearing potential (PONCBP) OR
- •Is a person of childbearing potential (POCBP)
- •A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.
排除标准
- •Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day
- •History of myocarditis, pericarditis, or myopericarditis.
- •History of Guillain-Barre syndrome.
- •Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
- •Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day
- •Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.
- •Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.
- •Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.
- •Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
- •Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.
- •Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22.
干预措施: Placebo (Biological)
mRNA-1018-H5 Vaccine
Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22.
干预措施: mRNA-1018-H5 (Biological)
结局指标
主要结局
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
时间窗: Day 43
HAI Titer \>=1:40.
Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay
时间窗: Day 43
Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 50 (28 days after each injection)
Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
时间窗: Day 1 to Day 205
次要结局
- Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay(Day 43)
- GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay(Days 22 and 205)
- GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay(Days 22 and 205)
- Percentage of Participants with HAI Titers at Different Cut-Offs(Up to Day 205)