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Virus Therapy

Combined RNA Vaccines for COVID-19 and Flu

Phase 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
For participants 65 years of age and older: participants who have received 4 or 5 prior doses of a modRNA SARS-CoV-2 vaccine, with the last dose being a bivalent vaccine, 120 days to 365 days before Visit 1 (Day 1)
Participants who have received at least 3 prior US-authorized mRNA COVID-19 vaccines, with the last dose being an updated (bivalent) vaccine given at least 150 days before Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1-, 4-, and 8 weeks after vaccination
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.
Select...
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.
Select...
If you're 65 or older, you must have received the flu shot at least 120 days before the study starts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before vaccination and at 1-, 4-, 8-weeks after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and before vaccination and at 1-, 4-, 8-weeks after vaccination for reporting.

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 more
Secondary 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 more

Trial 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
~5540

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
108,163 Total Patients Enrolled
20 Trials studying COVID-19
97,551 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,910,856 Total Patients Enrolled
67 Trials studying COVID-19
1,437,665 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,024 Total Patients Enrolled
49 Trials studying COVID-19
1,426,442 Patients Enrolled for COVID-19

Media Library

bivalent BNT162b2 (original/Omi BA.4/BA.5) (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05596734 — Phase 2
bivalent BNT162b2 (original/Omi BA.4/BA.5) (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05596734 — Phase 2
COVID-19 Research Study Groups: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7, SSA: qIRV + bivalent BNT162b2 (dose level combination 2), SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5), SSA: qIRV (dose level 2), SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2, SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4, SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6, SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5, SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8, SSB: qIRV, SSA: qIRV + bivalent BNT162b2 (dose level combination 3), SSA: qIRV (dose level 1), SSA: qIRV + bivalent BNT162b2 (dose level combination 1), SSA: bivalent BNT162b2 (dose level 1) + QIV, SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5), SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5), SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1, SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3
COVID-19 Clinical Trial 2023: bivalent BNT162b2 (original/Omi BA.4/BA.5) Highlights & Side Effects. Trial Name: NCT05596734 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants aged 80 or younger being admitted into this research project?

"This clinical trial requires that participants be no older than 64 years and at least 18 for enrollment."

Answered by AI

How secure is dose level 1 of qIRV for humans?

"Due to the nascent nature of this trial, qIRV (dose level 1) received a score of one for safety. This rating is based on limited data indicating efficacy and safety."

Answered by AI

How many health care facilities are conducting this experiment?

"The 19 sites currently running this study include The Heart Center in Orange, the Orange County Heart Institute in Tustin and the Orange County Research Center in Fort Lauderdale. Additionally, there are 16 other locations where research is being conducted."

Answered by AI

How many participants are taking part in this clinical research?

"In order to achieve the desired number of participants, 180 people that match the eligibility requirements must be recruited. Potential candidates can sign up at The Heart Center in Orange, California or Orange County Heart Institute located in Tustin, Florida."

Answered by AI

How many participants are still needed for this clinical trial?

"Indeed, according to information available on clinicaltrials.gov, this medical trial is presently recruiting patients. It was first uploaded to the website on October 28th 2022 and has been updated as recently as December 22nd 2022. The study aims to enroll 180 participants from 19 different sites across the country."

Answered by AI

What are the primary aims of this clinical experiment?

"This clinical trial, to be executed over one week with final assessment after vaccination, aims to evaluate the percentage of participants with newly-acquired ECG abnormalities. Additionally, it seeks to measure HAI titers ≥ 1:40 for each strain at a central laboratory and determine SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain neutralizing GMFRs via seroconversion tests conducted in the same laboratory setting."

Answered by AI

What are the eligibility requirements for participating in this clinical experiment?

"This clinical trial seeks 180 individuals aged 18-64 suffering from Covid19. In order to be eligible, applicants must demonstrate the capacity for informed consent, identify as male or female, comply with study visits and procedurers, have a healthy medical history verified by physical examination (if necessary), and have received 3 prior doses of BNT162b2 in the last 365 days preceding their first visit."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Orange County Research Center
Other
Orange County Heart Institute
Prolato Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

Why did patients apply to this trial?

Interested in clinical trials and like to get up to date and cutting edge vaccines if and when available.
PatientReceived 1 prior treatment
~421 spots leftby Apr 2025