A PHASE 2, RANDOMIZED, DOUBLE-BLIND, CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MRNA VACCINES AGAINST INFLUENZA IN ADULTS 18 YEARS OF AGE AND OLDER
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 770
- 试验地点
- 15
- 主要终点
- Percentage of participants reporting prespecified local reactions following vaccination
研究概览
简要总结
The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus).
This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison.
Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.
排除标准
- •Tested positive for influenza ≤5 months (150 days) prior to Visit 1 (Day 1).
- •Vaccination with any investigational or licensed influenza vaccine ≤5 months (150 days) before Visit 1 (Day 1).
- •Receipt of antiviral therapies for influenza (eg, Tamiflu) ≤5 months (150 days) prior to Visit 1 (Day 1).
研究组 & 干预措施
D
mRNA influenza vaccine candidate #4 as a single IM injection on Day 1.
干预措施: Vaccine Candidate #4 (Biological)
F
mRNA influenza vaccine candidate #6 as a single IM injection on Day 1.
干预措施: Vaccine Candidate #6 (Biological)
G
Licensed influenza vaccine (TIV1 or TIV2) as a single IM injection.
干预措施: TIV1 or TIV2 (Biological)
A
mRNA influenza vaccine candidate #1 as a single intramuscular (IM) injection on Day 1.
干预措施: Vaccine Candidate #1 (Biological)
B
mRNA influenza vaccine candidate #2 as a single IM injection on Day 1.
干预措施: Vaccine Candidate #2 (Biological)
C
mRNA influenza vaccine candidate #3 as a single IM injection on Day 1.
干预措施: Vaccine Candidate #3 (Biological)
E
mRNA influenza vaccine candidate #5 as a single IM injection on Day 1.
干预措施: Vaccine Candidate #5 (Biological)
结局指标
主要结局
Percentage of participants reporting prespecified local reactions following vaccination
时间窗: Within 7 days after vaccination
Percentage of participants reporting prespecified systemic events following vaccination.
时间窗: Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs) following vaccination.
时间窗: Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) following vaccination.
时间窗: Within 6 months after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination.
时间窗: Within 6 months after vaccination
次要结局
- Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine.(Before vaccination and at 4 weeks after vaccination)
- Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine(Before vaccination to 4 weeks after vaccination)
- Percentage of participants with satisfactory antibody response to the vaccine.(Before vaccination to 4 weeks after vaccination)