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NCT05227001 · ClinicalTrials.gov registry record · Phase 1

A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza

A Phase 1 study of Influenza, Human, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
440
Enrollment target
20
Study locations

NCT05227001 is a Phase 1 study of Influenza, Human that has completed, run by Pfizer. The registered enrollment target is 440 participants, below the 16,199-participant average among 18 other Influenza, Human trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT05227001, a Phase 1 study of Influenza, Human, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
440 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.

Conditions Studied

Influenza, Human

Interventions

  • BIOLOGICAL PF-07852352 Influenza saRNA 1
  • BIOLOGICAL PF-07836391 Influenza saRNA
  • BIOLOGICAL PF-07836394 Influenza saRNA
  • BIOLOGICAL PF-07836395 Influenza saRNA
  • BIOLOGICAL PF-07836396 Influenza saRNA

Study Locations (20)

Florida

  • Finlay Medical Research - Greenacres City
  • Advanced Pharma CR, LLC - Miami
  • Miami Clinical Research - Miami
  • Mount Sinai Hospital - Miami Beach
  • Panax Clinical Research - Miami Lakes
  • Pines Care Research Center, LLC - Pembroke Pines
  • Pinnacle Health Care Center - Pembroke Pines
  • Comprehensive Cardiology Consultants - Pembroke Pines

New York

  • NYU Langone Health - New York
  • SUNY Upstate Medical University Global Health Laboratory - Syracuse
  • SUNY Upstate Medical University Institute for Global Health - Syracuse
  • SUNY Upstate Medical University - Syracuse

Arizona

  • Arizona Heart Rhythm Center - Phoenix
  • Hope Research Institute - Phoenix
  • The Pain Center of Arizona - Phoenix

Nebraska

  • Pioneer Heart Institute - Lincoln
  • Velocity Clinical Research, Omaha - Omaha

California

  • Diablo Clinical Research, Inc. - Walnut Creek

Illinois

  • Great Lakes Clinical Trials - Andersonville - Chicago

Ohio

  • CTI Clinical Research Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2022-04-28
Est. Completion 2023-08-04
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05227001

The ClinicalTrials.gov registry entry for NCT05227001 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 16,199-participant average among 18 other Influenza, Human trials with a reported enrollment target (97% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 5 interventions - of which PF-07852352 Influenza saRNA 1 is the first listed.

NCT05227001 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, New York, Arizona.

Frequently Asked Questions

What is clinical trial NCT05227001 about?

NCT05227001 is a clinical study titled "A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza". The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49...

What is the current status of trial NCT05227001?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 440 participants. The study started on 2022-04-28. Estimated completion is 2023-08-04.

What conditions does trial NCT05227001 study?

This clinical trial studies the following conditions: Influenza, Human.

What interventions are being tested in trial NCT05227001?

The interventions under investigation include: PF-07852352 Influenza saRNA 1 (BIOLOGICAL), PF-07836391 Influenza saRNA (BIOLOGICAL), PF-07836394 Influenza saRNA (BIOLOGICAL), PF-07836395 Influenza saRNA (BIOLOGICAL), PF-07836396 Influenza saRNA (BIOLOGICAL).

Who is sponsoring clinical trial NCT05227001?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05227001 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.