A PHASE 1, RANDOMIZED, OBSERVER-BLIND, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST PANDEMIC INFLUENZA IN HEALTHY ADULTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 157
- 试验地点
- 6
- 主要终点
- Percentage of participants by age group reporting local reactions
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.
This study is seeking for participants who are:
- between the ages of 18 to 49 years old or 65 to 84 years old.
- willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures.
- healthy as confirmed by medical history, physical examinations, and the study doctor.
- capable of signing informed consent.
Participants will receive either:
- the pdmFlu vaccine,
- a licensed influenza vaccine
- a placebo. A placebo does not have any medicine in it but looks just like the study medicine.
Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm. The study will compare participant experiences to help understand if the pdmFlu vaccine is safe and effective. Participants will take part in this study for up to 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.
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
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
排除标准
- •- Does not meet seasonal influenza vaccine requirements per cohort.
研究组 & 干预措施
pdmFlu vaccine 1
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 2
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 3
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 4
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 5
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 6
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 7
干预措施: pdmFlu vaccine (Biological)
pdmFlu vaccine 8
干预措施: pdmFlu vaccine (Biological)
Placebo
干预措施: Placebo (Biological)
Licensed influenza vaccine
干预措施: Licensed influenza vaccine (Biological)
结局指标
主要结局
Percentage of participants by age group reporting local reactions
时间窗: For 7 days after vaccination
Percentage of participants by age group reporting adverse events
时间窗: From vaccination to 4 weeks after each vaccination
Percentage of participants by age group reporting systemic events
时间窗: For 7 days after vaccination
Percentage of participants by age group with new troponin I abnormalities
时间窗: 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group reporting serious adverse events
时间窗: From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
Percentage of participants by age group reporting medically attended adverse events
时间窗: From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
Percentage of participants by age group with abnormal hematology and chemistry laboratory values
时间窗: 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments
时间窗: Between baseline and 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with new clinically significant ECG abnormalities
时间窗: 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
次要结局
- Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers(At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination)
- Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint(At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination)
- Proportion of participants by age group achieving HAI seroconversion(At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination)
- Proportion of participants by age group with HAI titer >=1:40(At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination)