A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- BioNTech SE
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Percentage of participants reporting adverse events
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age.
This study is seeking participants who:
- are medically stable
- have not had a recent COVID-19 infection
- have not had a recent vaccination
- do not have medical conditions that increase their risk of complications from COVID-19
All participants in this study will randomly receive 1 injection into their arm of either:
- BNT162b2 vaccine which targets COVID-19 and is selected for the 2026-2027 COVID-19 season, or
- Tdap vaccine which targets tetanus, diphtheria, and pertussis (whooping cough).
The study team and participants will not know which injection they receive. We will evaluate safety and SARS-CoV-2 spike protein levels in people receiving each of these vaccines.
Participants will be in the study for about 12 months.
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 (Participant, Investigator)
盲法说明
Double-Blind, Third-Party-Unblinded
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Healthy participants 18 through 64 years of age who do not have medical conditions that put them at a higher risk for severe COVID-
排除标准
- •Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1
- •Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation.
- •The complete list of inclusion and exclusion criteria are listed in the protocol.
研究组 & 干预措施
Tdap Vaccine
Participants will receive a single injection containing Tdap on Day 1.
干预措施: Tdap Vaccine (Biological)
BNT162b2 Vaccine
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
干预措施: BNT162b2 Vaccine (Biological)
结局指标
主要结局
Percentage of participants reporting adverse events
时间窗: From Day 1 through 1 month after vaccination
Percentage of participants reporting serious adverse events
时间窗: From Day 1 through 12 months after vaccination
Spike protein levels
时间窗: Up to 12 months after vaccination
Percentage of participants reporting local reactions or systemic events
时间窗: From Day 1 up to 7 days after Vaccination
次要结局
未报告次要终点