A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED 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
- 1,353
- 试验地点
- 44
- 主要终点
- Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
研究概览
简要总结
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 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 judgment of the investigator to be eligible for inclusion in the study.
排除标准
- •Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine.
- •Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1
- •Please refer to the study contact for further eligibility details.
研究组 & 干预措施
Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
干预措施: COVID-19 Vaccine (Biological)
Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
干预措施: Licensed Influenza Vaccine 1 (Biological)
Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
干预措施: Licensed Influenza Vaccine 2 (Biological)
Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
干预措施: COVID-19 Vaccine (Biological)
Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm C/CC
High Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
干预措施: Investigational Influenza Vaccine (Biological)
Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
干预措施: Placebo (Other)
Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
干预措施: Investigational Influenza Vaccine (Biological)
Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
干预措施: Placebo (Other)
Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
干预措施: Investigational Influenza Vaccine (Biological)
Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
干预措施: Placebo (Other)
Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
干预措施: Placebo (Other)
Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
干预措施: Investigational Influenza/COVID-19 Vaccine (Combination Product)
Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
干预措施: COVID-19 Vaccine (Biological)
Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
干预措施: COVID-19 Vaccine (Biological)
Arm C/CC
High Dose COVID-19 Vaccine and Placebo
干预措施: COVID-19 Vaccine (Biological)
结局指标
主要结局
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
时间窗: Day 7
Describe prompted local reactions following investigational product administration
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
时间窗: Day 7
Describe prompted systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
时间窗: 4 weeks after vaccination
Describe AEs occurring through 4 weeks following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
时间窗: 6 months after vaccination
Describe SAEs through 6 months following administration of investigational product
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
时间窗: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
时间窗: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
时间窗: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
时间窗: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
时间窗: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
次要结局
未报告次要终点