Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 8
- 主要终点
- Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
研究概览
简要总结
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to <50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
- •Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the screening visit.
排除标准
- •Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit.
- •Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine.
- •Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- •Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection.
- •Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-
- •Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-
- •Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day
- •SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable.
- •Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
- •Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part 1: mRNA-1345
Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
干预措施: mRNA-1345 (Biological)
Part 1: mRNA-1647 2-Dose
Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.
干预措施: mRNA-1647 (Biological)
Part 1: mRNA-1647 3-Dose
Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
干预措施: mRNA-1647 (Biological)
Part 2: mRNA-1273
Participants will receive single IM injection of mRNA-1273 on Day 1
干预措施: mRNA-1273 (Biological)
Part 2: mRNA-1010
Participants will receive single IM injection of mRNA-1010 on Day 1.
干预措施: mRNA-1010 (Biological)
Part 2: FLUAD®
Participants will receive single IM injection of FLUAD® on Day 1.
干预措施: FLUAD® (Biological)
结局指标
主要结局
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
时间窗: Up to Day 176 (7 days follow-up post-vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
时间窗: Up to Day 197 (28 days follow-up post-vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: Day 1 through Day 361
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
时间窗: Day 1 through end of study (EOS) (up to Day 1249)
次要结局
- Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345(Days 1 (Baseline), 29, 85, and 197)
- Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647(Days 1 (Baseline), 29, 85, and 197)
- Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345(Days 1 (Baseline), 29, 85, and 197)