A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY AND EFFICACY OF A VARIANT-ADAPTED BNT162B2 VACCINE IN HEALTHY PARTICIPANTS 50 THROUGH 64 YEARS OF AGE
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
- 入组人数
- 5,240
- 试验地点
- 380
- 主要终点
- Percentage of participants reporting local reactions or systemic events
研究概览
简要总结
This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect against COVID-19 (placebo).
详细描述
The study is designed to evaluate if the COVID-19 vaccine reduces COVID-19 disease as compared to placebo given to healthy adults 50 to 64 years of age. Approximately 25,500 participants will be randomly chosen to get either one dose of COVID-19 vaccine or of a placebo.
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
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who are between 50 and 64 years old at their first appointment.
- •People who are healthy and, based on their medical history and a doctor's judgment, are considered suitable to join the study.
排除标准
- •People who had COVID-19 in the past 3 months (90 days) before their first visit.
- •People who got a COVID-19 vaccine, either as part of a research study or an approved vaccine, in the last 3 months-or plans to get one during the study.
研究组 & 干预措施
BNT162b2 Vaccine
干预措施: BNT162b2 Vaccine (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Percentage of participants reporting local reactions or systemic events
时间窗: From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events
时间窗: From Day 1 through 4 weeks after vaccination
Percentage of participants reporting serious adverse events
时间窗: From Day 1 through 6 months after vaccination
First episode of confirmed COVID-19 cases
时间窗: From 0 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination
次要结局
- First episode of confirmed COVID-19 cases(From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination)
- Geometric Mean Ratio (GMR)(From before vaccination to 1 month after vaccination)