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RNA Vaccine

qIRV for Flu

Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
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 prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
Awards & highlights

Study Summary

This trial will have two substudies - Substudy A and Substudy B. Substudy A will look at the safety and immunogenicity of different influenza vaccines in people aged 65-85, while Substudy B will look at different vaccination schedules in people aged 65-85.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
+32 more
Secondary outcome measures
Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
+23 more

Trial Design

28Treatment groups
Experimental Treatment
Group I: SSB: qIRV (dose level 3), 1-visit scheduleExperimental Treatment1 Intervention
NOTE: Arm Description has not been entered
Group II: SSB: qIRV (dose level 2, dose combination 2), 1-visit scheduleExperimental Treatment1 Intervention
NOTE: Arm Description has not been entered
Group III: SSB: qIRV (dose level 2, dose combination 1), 1-visit scheduleExperimental Treatment1 Intervention
NOTE: Arm Description has not been entered.
Group IV: SSB: qIRV (dose level 2), 1-visit scheduleExperimental Treatment1 Intervention
NOTE: Arm Description has not been entered.
Group V: SSB: qIRV (dose level 1), 1-visit scheduleExperimental Treatment1 Intervention
NOTE: Arm Description has not been entered.
Group VI: SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit scheduleExperimental Treatment2 Interventions
NOTE: Arm Description has not been entered
Group VII: SSB: QIV + bIRV AA (dose level combination 2), 2-visit scheduleExperimental Treatment2 Interventions
Group VIII: SSB: QIV + bIRV AA (dose level combination 2), 1-visit scheduleExperimental Treatment2 Interventions
Group IX: SSB: QIV + bIRV AA (dose level combination 1), 2-visit scheduleExperimental Treatment2 Interventions
Group X: SSB: QIV + bIRV AA (dose level combination 1), 1-visit scheduleExperimental Treatment2 Interventions
Group XI: SSB: 2 doses of qIRV (dose level 1), 2-visit scheduleExperimental Treatment1 Intervention
Group XII: SSB: 2 doses of QIV, 2-visit scheduleExperimental Treatment1 Intervention
Group XIII: SSB: 1 dose of QIV, 1-visit scheduleExperimental Treatment1 Intervention
NOTE: Arm Description has not been entered
Group XIV: SSA: qIRV (dose level 1) + QIVExperimental Treatment2 Interventions
Group XV: SSA: mIRV B (dose level 4) + QIVExperimental Treatment2 Interventions
Group XVI: SSA: mIRV B (dose level 3) + QIVExperimental Treatment2 Interventions
Group XVII: SSA: mIRV B (dose level 2) + QIVExperimental Treatment2 Interventions
Group XVIII: SSA: mIRV B (dose level 1) + QIVExperimental Treatment2 Interventions
Group XIX: SSA: mIRV A (dose level 4) + QIVExperimental Treatment2 Interventions
Group XX: SSA: mIRV A (dose level 3) + QIVExperimental Treatment2 Interventions
Group XXI: SSA: mIRV A (dose level 2) + QIVExperimental Treatment2 Interventions
Group XXII: SSA: mIRV A (dose level 1) + QIVExperimental Treatment2 Interventions
Group XXIII: SSA: bIRV AB (dose level combination 4) + QIVExperimental Treatment2 Interventions
Group XXIV: SSA: bIRV AB (dose level combination 3) + QIVExperimental Treatment2 Interventions
Group XXV: SSA: bIRV AB (dose level combination 2) + QIVExperimental Treatment2 Interventions
Group XXVI: SSA: bIRV AB (dose level combination 1) + QIVExperimental Treatment2 Interventions
Group XXVII: SSA: QIV + mIRV B strain (dose level 4)Experimental Treatment2 Interventions
Group XXVIII: SSA: QIV + mIRV A strain (dose level 4)Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
qIRV
2021
Completed Phase 2
~1620
bIRV AA
2021
Completed Phase 2
~1160
bIRV BB
2021
Completed Phase 2
~1160
QIV
2022
Completed Phase 3
~5540
mIRV
2021
Completed Phase 2
~1160
bIRV AB
2021
Completed Phase 2
~1160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,906,525 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,087,962 Total Patients Enrolled

Frequently Asked Questions

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

Is it possible to sign up for this trial currently?

"Yes, this is an active trial according to the information available on clinicaltrials.gov. The listing says that the study was first posted on 9/13/2021 and last updated on 10/18/2022. They are looking for a total of 1980 patients at 100 different sites."

Answered by AI

How can I sign up to be a test subject for this research?

"This trial is looking for 1980 participants aged 18 to 85 who have influenza. Additionally, patients must meet the following criteria: Substudy A – Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures., Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study., Capable of giving signed informed consent., Male or female participants 65 to 85 years of age., Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not"

Answered by AI

What difference do researchers expect this study will make?

"The purpose of this clinical trial is to assess the percentage of participants reporting systemic events (between the ages of 18 and 64, as well as 65 and 85) over a one-week period after receiving vaccination. Additionally, secondary outcomes being monitored include geometric mean titers (GMTs) of hemagglutination inhibition (HAI) – which will be measured at central laboratories – for participants aged 65 to 85, as well as the proportion of participants in this age group who achieve HAI seroconversion for each strain."

Answered by AI

Does this study allow elderly patients to participate?

"According to the inclusion criteria found on this clinical trial's website, patients must be aged 18 to 85. There are currently 39 trials ongoing for individuals who are under 18 and 76 studies for people over the age of 65."

Answered by AI

How many test subjects are in this clinical trial?

"To successfully complete this clinical trial, 1980 eligible individuals are required to participate. Patients can choose to partake in this study at different sites such as Invesclinic US LLC located in Davie, Florida and Meridian Clinical Research LLC based in Omaha, Nebraska."

Answered by AI

Are there any other research facilities besides those in North America conducting this experiment?

"100 different research facilities are conducting this study, like Invesclinic US LLC in Davie, Meridian Clinical Research LLC in Omaha, Progressive Medical Research in Port Orange, and many others."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Arizona
Texas
How old are they?
18 - 65
What site did they apply to?
DM Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~331 spots leftby Mar 2025