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RNA Vaccine

PF-07836395 Influenza saRNA for Flu

Phase 1
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1-, 2-, and 4-weeks after vaccination
Awards & highlights

Study Summary

This trial is to see if a new vaccine for the flu is safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-, 2-, and 4-weeks after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1-, 2-, and 4-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
Percentage of participants reporting adverse events
Percentage of participants reporting local reactions
Percentage of participants reporting serious adverse events
+5 more
Secondary outcome measures
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
Proportion of participants achieving HAI seroconversion for each strain
+1 more

Trial Design

26Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PF-07915048 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group II: PF-07914705 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group III: PF-07914705 Influenza saRNA mid doseExperimental Treatment1 Intervention
Group IV: PF-07871987 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group V: PF-07871987 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group VI: PF-07871987 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group VII: PF-07867246 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group VIII: PF-07867246 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group IX: PF-07867246 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group X: PF-07852352 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group XI: PF-07852352 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group XII: PF-07852352 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group XIII: PF-07836396 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group XIV: PF-07836396 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group XV: PF-07836396 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group XVI: PF-07836395 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group XVII: PF-07836395 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group XVIII: PF-07836395 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group XIX: PF-07836394 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group XX: PF-07836394 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group XXI: PF-07836394 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group XXII: PF-07836391 Influenza saRNA, mid doseExperimental Treatment1 Intervention
Group XXIII: PF-07836391 Influenza saRNA, low doseExperimental Treatment1 Intervention
Group XXIV: PF-07836391 Influenza saRNA, high doseExperimental Treatment1 Intervention
Group XXV: Quadrivalent influenza vaccine (QIV)Active Control1 Intervention
Group XXVI: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07867246 Influenza saRNA
2022
Completed Phase 1
~450
PF-07915048 Influenza saRNA
2022
Completed Phase 1
~450
PF-07871987 Influenza saRNA
2022
Completed Phase 1
~450
PF-07914705 Influenza saRNA
2022
Completed Phase 1
~450
PF-07852352 Influenza saRNA 1
2022
Completed Phase 1
~450
PF-07836391 Influenza saRNA
2022
Completed Phase 1
~450
PF-07836394 Influenza saRNA
2022
Completed Phase 1
~450
PF-07836395 Influenza saRNA
2022
Completed Phase 1
~450
PF-07836396 Influenza saRNA
2022
Completed Phase 1
~450

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,431 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,599 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 there a specific criteria that potential participants must meet to qualify for this experiment?

"This clinical trial is seeking 468 individuals between 18 and 49 years old who have been infected with the influenza virus. In order to be eligible, male candidates must agree to use contraception if they are able of fathering children, while female applicants must not possess child-bearing capabilities; all participants should demonstrate their willingness and ability to adhere to the scheduled visits, treatments plans, laboratory tests etc. Furthermore, volunteers need to be certified as healthy by a medical history review and physical examination (if necessary). Lastly, consent forms will need to be signed in order for an individual's eligibility status to be confirmed."

Answered by AI

Is this medical experiment open to participants at present?

"The trial, which was first announced on the 28th of April 2022, is in its recruiting phase. The most recent update to this study came through on October 24th 2022 according to clinicaltrials.gov."

Answered by AI

What is the scope of participants in this clinical investigation?

"This medical experiment necessitates 468 qualified participants to partake, who are able to do so from either Pinnacle Health Care Center in Pembroke Pines or The Pain Center of Arizona in Phoenix."

Answered by AI

Is participation in this trial restricted to individuals older than 75 years of age?

"Adhering to the trial's inclusion regulations, only those aged 18-49 are eligible for enrollment."

Answered by AI

Are there any medical centers in North America administering this clinical investigation?

"The current clinical trial is recruiting patients from a wide array of medical centres, including Pinnacle Health Care Center in Pembroke Pines, Florida; The Pain Center of Arizona in Phoenix, Arizona; and the prestigious Pines Care Research Centre LLC based out of Syracuse, New york. A full list of 25 other eligible locations can be found online."

Answered by AI

What is the desired outcome of this experiment?

"As per the study's sponsor, Pfizer, Percentage of participants experiencing systemic events within a 7 day post-vaccination period is the primary observation metric. Secondary metrics include Geometric mean titers (GMTs) analysis at central laboratories for hemagglutination inhibition (HAI), plus Proportion of patients achieving HAI seroconversion and those with an antibody titer exceeding 1:40 as again assessed by a centralized laboratory."

Answered by AI

Has PF-07836395 Influenza saRNA been deemed secure for human use?

"As this is a Phase 1 trial, with limited data in regards to safety and efficacy, the Power team has assigned PF-07836395 Influenza saRNA a score of one on our scale."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Pinnacle Health Care Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
~152 spots leftby Apr 2025