A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

Study Overview
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Brief Summary
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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 7500 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance. Cohort 1: Around 4500 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 the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm. Group B: Licensed influenza vaccine, given at the same time to the right arm and COVID-19 Vaccine in the left arm. Cohort 2: Around 3000 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 the right arm and placebo in the left arm. Group D: Licensed influenza vaccine, given at the same time in the right arm and COVID-19 in the left arm. All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.

Official Title
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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

Conditions
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Influenza, COVID-19

Intervention / Treatment
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* Biological: Influenza and COVID-19 Combination A
* Biological: Licensed influenza vaccine
* Biological: COVID-19 Vaccine
* Biological: Influenza and COVID-19 Combination B
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria: Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration. Please refer to the study contact for further eligibility details

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo<br>Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo | Biological: Influenza and COVID-19 Combination A<br>* Combined influenza and Pfizer-BioNTech COVID-19 Vaccine<br>Biological: Placebo<br>* Saline Solution<br>|
| Active Comparator: Cohort 1 Arm B: Licensed influenza vaccine and COVID-19 concomitant administration group<br>Cohort 1 Arm B: Licensed influenza vaccine and COVID-19 concomitant administration group | Biological: Licensed influenza vaccine<br>* Licensed influenza vaccine<br>Biological: COVID-19 Vaccine<br>* Pfizer-BioNTech COVID-19 vaccine<br>|
| Experimental: Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo<br>Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo | Biological: Influenza and COVID-19 Combination B<br>* Combined influenza and Pfizer-BioNTech COVID-19 vaccine<br>Biological: Placebo<br>* Saline Solution<br>|
| Active Comparator: Cohort 2 Arm D: Licensed influenza vaccine and COVID-19 concomitant administration group<br>Cohort 2 Arm D: Licensed influenza vaccine and COVID-19 concomitant administration group | Biological: Licensed influenza vaccine<br>* Licensed influenza vaccine<br>Biological: COVID-19 Vaccine<br>* Pfizer-BioNTech COVID-19 vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants reporting prompted local reactions within 7 days following investigational product administration in the right deltoid | Describe prompted local reactions following investigational product administration | Day 7 | 
| Percentage of participants reporting prompted systemic events within 7 days following investigational product administration | Describe prompted systemic events following investigational product administration | Day 7 | 
| Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration | Describe AEs occurring through 4 weeks following administration of investigational product | 4 weeks after vaccination | 
| Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration | Describe SAEs through 1 month following administration of investigational product | 6 months after vaccination | 
| GMR of HAI titers in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by licensed influenza vaccine and COVID-19 concomitant administration group | 4 weeks after vaccination | 
| The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by Licensed influenza vaccine and COVID-19 concomitant administration group. | 4 weeks after vaccination | 
| GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination A recipients compared to participants having received licensed influenza vaccine and COVID-19 concomitant administration group at 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination | 
| The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to subjects having received licensed influenza vaccine and COVID-19 concomitant administration group | To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination | 
| GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19 | 4 weeks after vaccination | 
| The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19 | 4 weeks after vaccination | 
| GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination | 
| The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19 | To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine | 4 weeks after vaccination |