A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
第3相
完了
NCT06178991
| 対象疾患 | Influenza, COVID-19 |
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| 相 | 第3相 |
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| スポンサー | BioNTech SE |
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| ステータス | 完了 |
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| 参加者数 | 8,795 名 |
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| 介入（薬剤） | 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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| 開始日 | 2023年12月20日 |
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| 完了日 | 2024年11月26日 |
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| 結果公開日 | 2025年12月4日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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