Study Summary
This trial will study the safety and effectiveness of 3 doses of a quadrivalent and bivalent flu vaccine.
- Coronavirus
- Flu
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 9 Secondary · Reporting Duration: At 1-, 4-, and 8 weeks after vaccination
Trial Safety
Safety Progress
Trial Design
6 Treatment Groups
qIRV + bivalent BNT162b2 (dose level combination 1)
1 of 6
qIRV + bivalent BNT162b2 (dose level combination 2)
1 of 6
qIRV + bivalent BNT162b2 (dose level combination 3)
1 of 6
qIRV (dose level 1)
1 of 6
qIRV (dose level 2)
1 of 6
bivalent BNT162b2 (dose level 1) + QIV
1 of 6
Experimental Treatment
360 Total Participants · 6 Treatment Groups
Primary Treatment: qIRV + bivalent BNT162b2 (dose level combination 1) · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 64 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor