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Virus Therapy
Combined RNA Vaccines for COVID-19 and Flu
Phase 1 & 2
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before vaccination and at 1-, 4-, 8-weeks after vaccination
Awards & highlights
Summary
This trial will study the safety and effectiveness of 3 doses of a quadrivalent and bivalent flu vaccine.
Who is the study for?
Adults aged 18+ who've had at least 3 prior mRNA COVID-19 vaccines, with the last being a bivalent dose given over 150 days ago. For those 65+, they must have received an influenza vaccine for the current season and additional COVID-19 vaccine doses. Participants should be healthy, able to follow study procedures, and not involved in strenuous exercise or have heart disease, bleeding issues, immunodeficiency, severe allergies to vaccines or their components.Check my eligibility
What is being tested?
The trial is testing combined modified RNA vaccines against COVID-19 and flu. Substudy A tests different dose combinations of qIRV (22/23) & bivalent BNT162b2 (original/Omi BA.4/BA.5). Substudy B examines safety and immune response when these are administered with licensed flu vaccines like QIV.See study design
What are the potential side effects?
Potential side effects may include typical reactions at injection sites such as pain or swelling, general symptoms like fever or fatigue, allergic responses ranging from mild to severe (anaphylaxis), muscle aches, headaches and possibly temporary changes in blood test results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1-, 4-, and 8 weeks after vaccination.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-, 4-, and 8 weeks after vaccination.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SSA: Percentage of participants reporting adverse events
SSA: Percentage of participants reporting local reactions
SSA: Percentage of participants reporting serious adverse events
+10 moreSecondary outcome measures
SSA: GMFRs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers
SSA: Geometric Mean Fold Rise (GMFRs) of HAI titers
+15 moreTrial Design
18Treatment groups
Experimental Treatment
Group I: SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group II: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group III: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group IV: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group V: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group VI: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group VII: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group VIII: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group IX: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group X: SSB: qIRVExperimental Treatment1 Intervention
Administered intramuscularly into the deltoid muscle of the right arm
Group XI: SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)Experimental Treatment2 Interventions
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Group XII: SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)Experimental Treatment3 Interventions
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Group XIII: SSA: qIRV + bivalent BNT162b2 (dose level combination 3)Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group XIV: SSA: qIRV + bivalent BNT162b2 (dose level combination 2)Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group XV: SSA: qIRV + bivalent BNT162b2 (dose level combination 1)Experimental Treatment2 Interventions
Administered intramuscularly into the deltoid muscle of the right arm
Group XVI: SSA: qIRV (dose level 2)Experimental Treatment1 Intervention
Administered intramuscularly into the deltoid muscle of the right arm
Group XVII: SSA: qIRV (dose level 1)Experimental Treatment1 Intervention
Administered intramuscularly into the deltoid muscle of the right arm
Group XVIII: SSA: bivalent BNT162b2 (dose level 1) + QIVExperimental Treatment2 Interventions
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tIRV
2022
Completed Phase 2
~1020
bIRV
2022
Completed Phase 2
~1020
bivalent BNT162b2 (original/Omi BA.4/BA.5)
2022
Completed Phase 2
~1020
qIRV (22/23)
2022
Completed Phase 2
~1020
QIV
2022
Completed Phase 3
~5550
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BioNTech SELead Sponsor
69 Previous Clinical Trials
107,083 Total Patients Enrolled
20 Trials studying COVID-19
95,705 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,867,751 Total Patients Enrolled
67 Trials studying COVID-19
1,436,020 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,044,360 Total Patients Enrolled
50 Trials studying COVID-19
1,424,821 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ECG shows signs of heart inflammation or other significant abnormalities that could affect your safety or the study results.You have a condition that causes prolonged bleeding.If you are 65 years or older, you've had 4 or 5 doses of an mRNA COVID-19 vaccine, including a bivalent vaccine, within the last 120 to 365 days before the start of the study.You have received three mRNA COVID-19 vaccines authorized in the US, with the most recent one being an updated vaccine given at least 150 days ago.You have a weakened immune system due to a known or suspected immune disorder.You shouldn't do very intense exercise until Visit 3 of the study.Your troponin I blood test results are not normal.You have received an experimental or approved flu vaccine within the last 6 months, or you are currently taking long-term medication for the flu.You have a weakened immune system due to a medical condition or medications.You are allergic to eggs or chicken.You have a medical or mental health condition, or recent thoughts of harming yourself, that could make it risky for you to take part in the study.You received an experimental or approved flu vaccine within the past 6 months.You have had heart problems before.Your heart test shows signs of possible heart inflammation or other important issues that could affect your safety or the study results.You have a condition that causes prolonged bleeding and makes it unsafe for you to receive injections into the muscle.If you are between 18 and 64 years old, you have received 3 doses of the BNT162b2 vaccine, and the last dose was given between 150 to 365 days before the start of the study.If you're 65 or older, you must have received the flu shot at least 120 days before the study starts.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7
- Group 2: SSA: qIRV + bivalent BNT162b2 (dose level combination 2)
- Group 3: SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)
- Group 4: SSA: qIRV (dose level 2)
- Group 5: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2
- Group 6: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4
- Group 7: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6
- Group 8: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5
- Group 9: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8
- Group 10: SSB: qIRV
- Group 11: SSA: qIRV + bivalent BNT162b2 (dose level combination 3)
- Group 12: SSA: qIRV (dose level 1)
- Group 13: SSA: qIRV + bivalent BNT162b2 (dose level combination 1)
- Group 14: SSA: bivalent BNT162b2 (dose level 1) + QIV
- Group 15: SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)
- Group 16: SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)
- Group 17: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1
- Group 18: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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