A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
3期
已完成
NCT06178991
| 适应症 | Influenza, COVID-19 |
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| 分期 | 3期 |
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| 申办方 | BioNTech SE |
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| 状态 | 已完成 |
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| 受试者人数 | 8,795 人 |
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| 干预（药物） | Influenza and COVID-19 Combination A, Licensed influenza vaccine, COVID-19 Vaccine, Influenza and COVID-19 Combination B, Investigational influenza vaccine |
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| 开始日期 | 2023年12月20日 |
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| 完成日期 | 2024年11月26日 |
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| 结果公布日 | 2025年12月4日 |
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摘要
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance. Cohort 1: Approximately 450 participants will be assigned by chance to one of the following: * Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm. * Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm. Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following: * Group C: Influenza and COVID-19 combination B
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] · Percentage of participants
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 74.7 Percentage of participants |
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| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 59.1 Percentage of participants |
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Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
From Day 1 through Day 7 after Vaccination [Vaccination on Day1] · Percentage of participants
| Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | 73.4 Percentage of participants |
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| Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 63.5 Percentage of participants |
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Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] · Percentage of participants
| Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | 73.4 Percentage of participants |
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| Cohort 3, Arm F: COVID-19 Vaccine | 62.5 Percentage of participants |
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| Cohort 3, Arm G: Licensed Influenza Vaccine | 34.8 Percentage of participants |
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| Cohort 3, Arm H: Investigational Influenza Vaccine | 66.3 Percentage of participants |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。