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Combined RNA Vaccines for COVID-19 and Flu
Study Summary
This trial will study the safety and effectiveness of 3 doses of a quadrivalent and bivalent flu vaccine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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 have been taking strong medications that weaken your immune system or have had radiation treatment in the last 60 days.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.
- 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.
- Group 1: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6
- Group 2: SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5)
- Group 3: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8
- Group 4: SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5)
- 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 1
- Group 7: SSB: qIRV
- Group 8: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3
- Group 9: SSA: bivalent BNT162b2 (dose level 1) + QIV
- Group 10: SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)
- Group 11: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7
- Group 12: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4
- Group 13: SSA: qIRV + bivalent BNT162b2 (dose level combination 3)
- Group 14: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5
- Group 15: SSA: qIRV + bivalent BNT162b2 (dose level combination 1)
- Group 16: SSA: qIRV (dose level 1)
- Group 17: SSA: qIRV + bivalent BNT162b2 (dose level combination 2)
- Group 18: SSA: qIRV (dose level 2)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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