A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 2,650
- 试验地点
- 31
- 主要终点
- Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
研究概览
简要总结
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.
This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.
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
- •Participants 18 years of age or older
- •Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study
排除标准
- •Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
- •Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
- •Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day
- •Refer to the study contact for further eligibility details
研究组 & 干预措施
Arm SS
Licensed Influenza Vaccine (3)
干预措施: Licensed Influenza Vaccine 3 (Biological)
Arm A
Low Dose COVID-19 Vaccine (1a)
干预措施: Investigational COVID-19 Vaccine (Biological)
Arm B
Low Dose COVID-19 Vaccine ( 1b)
干预措施: Investigational COVID-19 Vaccine (Biological)
Arm C
Low Dose COVID-19 Vaccine ( 1c)
干预措施: Investigational COVID-19 Vaccine (Biological)
Arm D
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm E
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm F
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm G
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm H
Licensed COVID-19 Vaccine
干预措施: Licensed COVID-19 Vaccine (Biological)
Arm I
Licensed Influenza Vaccine (1)
干预措施: Licensed Influenza Vaccine 1 (Biological)
Arm J
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm K
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm L
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm M
Licensed COVID-19 Vaccine
干预措施: Licensed COVID-19 Vaccine (Biological)
Arm N
Licensed Influenza Vaccine (2)
干预措施: Licensed Influenza Vaccine 2 (Biological)
Arm AA
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm BB
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm CC
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm DD
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm EE
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm FF
Licensed COVID-19 Vaccine
干预措施: Licensed COVID-19 Vaccine (Biological)
Arm GG
Licensed Influenza Vaccine (3)
干预措施: Licensed Influenza Vaccine 3 (Biological)
Arm HH
Licensed Influenza Vaccine (2)
干预措施: Licensed Influenza Vaccine 2 (Biological)
Arm II
Low Dose COVID-19 Vaccine ( 1b)
干预措施: Investigational COVID-19 Vaccine (Biological)
Arm JJ
Low Dose COVID-19 Vaccine ( 1c)
干预措施: Investigational COVID-19 Vaccine (Biological)
Arm KK
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm LL
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm MM
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm NN
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm OO
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
干预措施: Investigational Influenza and COVID-19 Combination Vaccine (Combination Product)
Arm PP
Medium Dose Investigational Influenza Vaccine (1)
干预措施: Investigational Influenza Vaccine (Biological)
Arm QQ
High Dose Investigational Influenza Vaccine (2)
干预措施: Investigational Influenza Vaccine (Biological)
Arm RR
Licensed COVID-19 Vaccine
干预措施: Licensed COVID-19 Vaccine (Biological)
结局指标
主要结局
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
时间窗: Day 7
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
时间窗: Day 7
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
时间窗: 1 month
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
时间窗: 6 months
次要结局
- GMTs before and through 1 month following investigational product administration(Before vaccination through to 1 month after vaccination)