Combined Vaccine for COVID-19 and Flu
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: BioNTech SE
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for healthy adults aged 18-64 who haven't had any flu or COVID-19 vaccines in the past 6 months. They must pass a medical review and possibly a physical exam to join.Inclusion Criteria
I am between 18 and 64 years old.
Exclusion Criteria
I haven't had a flu shot or taken flu antiviral drugs in the last 6 months.
Treatment Details
The study tests a combined vaccine for influenza and COVID-19 against separate vaccinations for each virus. Participants are randomly placed into one of four groups, receiving either combined or individual vaccines.
8Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3 Arm E:Influenza and COVID-19 Combination BExperimental Treatment1 Intervention
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Group II: Cohort 2 Arm C:Influenza and COVID-19 Combination B and PlaceboExperimental Treatment2 Interventions
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Group III: Cohort 1 Arm A: Influenza and COVID-19 Combination A and PlaceboExperimental Treatment2 Interventions
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Group IV: Cohort 3 Arm F: COVID-19 vaccineActive Control1 Intervention
Cohort 3 Arm F: COVID-19 vaccine
Group V: Cohort 3 Arm G: Licensed influenza vaccineActive Control1 Intervention
Cohort 3 Arm G: Licensed influenza vaccine
Group VI: Cohort 3 Arm H: Investigational influenza vaccineActive Control1 Intervention
Cohort 3 Arm H: Investigational influenza vaccine
Group VII: Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration groupActive Control2 Interventions
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Group VIII: Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration groupActive Control2 Interventions
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Find a clinic near you
Research locations nearbySelect from list below to view details:
AGILE Clinical Research Trials, LLCSandy Springs, GA
Great Lakes Clinical Trials - RavenswoodChicago, IL
Saint Louis University Center for Vaccine DevelopmentSaint Louis, MO
Velocity Clinical Research, OmahaOmaha, NE
More Trial Locations
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Who is running the clinical trial?
BioNTech SELead Sponsor
PfizerIndustry Sponsor