Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178991
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-12-20
Brief Title:
A Study to Evaluate the Safety Tolerability and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 AInfluenza 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 bodys reaction to the vaccination over approximately 6 months This will help understand if the study medicine is safe
Cohort 1 Approximately 450 participants will be assigned by chance to one of the following
Group AInfluenza 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 bodys reaction to the vaccination over approximately 6 months This will help understand if the study medicine is safe
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None