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项与 Bivalent influenza modRNA vaccine (BioNTech/Pfizer) 相关的临床试验A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
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 vaccine, given at the same time in one arm and placebo in the opposite arm.
* Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.
Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:
* Group E: Influenza and COVID-19 combination B vaccine.
* Group F: COVID-19 vaccine.
* Group G: Licenced influenza vaccine.
* Group H: Investigational influenza vaccine.
All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.
A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either:
* qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations
* qIRV (22/23) at dose level 1,
* qIRV (22/23) at dose level 2, or
* bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV).
Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).
A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB)
Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:
1 of 4 dose levels of mIRV (either A or B Strain),
1 of 4 dose levels of bIRV (containing both A and B strains),
qIRV (at 1 dose level), or
A licensed quadrivalent influenza vaccine (QIV).
At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:
mIRV encoding A strain at dose level 4, or
mIRV encoding B strain at dose level 4.
Substudy B
This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age:
2-Visit Schedules
2 doses of qIRV (at a dose level 1), administered 21 days apart.
2 doses of licensed QIV, administered 21 days apart (as a control group)
A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart.
1-Visit Schedules
A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2.
A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1.
A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations).
A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3.
1 dose of licensed QIV (as a control group).
Substudy B
In participants 18 to 64 years of age:
-A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.
100 项与 Bivalent influenza modRNA vaccine (BioNTech/Pfizer) 相关的临床结果
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