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

A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Placebo; 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; Biological: PF-07867246 Influenza saRNA; Biological: Quadrivalent influenza vaccine (QIV); Biological: PF-07871987 Influenza saRNA; Biological: PF-07914705 Influenza saRNA; Biological: PF-07915048 Influenza saRNA

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Rhythm Center
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85018
      • The Pain Center of Arizona
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Hospital
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
    • Pembroke Pines, Florida, United States, 33024
      • Pines Care Research Center, LLC
    • Pembroke Pines, Florida, United States, 33024
      • Pinnacle Health Care Center
    • Pembroke Pines, Florida, United States, 33028
      • Comprehensive Cardiology Consultants
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Andersonville
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Pioneer Heart Institute
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Syracuse, New York, United States, 13215
      • SUNY Upstate Medical University
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University Global Health Laboratory
    • Syracuse, New York, United States, 13215
      • SUNY Upstate Medical University Institute for Global Health
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • Austin, Texas, United States, 78705
      • Eric S. Tiblier, MD
    • Tomball, Texas, United States, 77375
      • DM Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female participants 18 to 49 years of age.
• 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.
• Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Allergy to egg proteins (egg or egg products) or chicken proteins.
• Participant who has had significant exposure to laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection), coronavirus disease 2019 (COVID-19), or influenza in the past 14 days known prior to Visit 1
• Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative.
• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
• Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration.
• Any participant who has received or plans to receive a nucleoside-modified messenger ribonucleic acid (modRNA)-platform SARS-CoV-2 vaccine within 60 days of Visit 1
• Previous vaccination with an saRNA or an alphavirus replicon vaccine preparation.
• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
• Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator.
• Screening electrocardiogram (ECG) that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results.
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
• Participation in strenuous or endurance exercise through Visit 3.
• Prior history of heart disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

26

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Intramuscular injection
Experimental: PF-07852352 Influenza saRNA, low dose	Biological: PF-07852352 Influenza saRNA 1; Intramuscular injection
Experimental: PF-07852352 Influenza saRNA, mid dose	Biological: PF-07852352 Influenza saRNA 1; Intramuscular injection
Experimental: PF-07852352 Influenza saRNA, high dose	Biological: PF-07852352 Influenza saRNA 1; Intramuscular injection
Experimental: PF-07836391 Influenza saRNA, low dose	Biological: PF-07836391 Influenza saRNA; Intramuscular injection
Experimental: PF-07836391 Influenza saRNA, mid dose	Biological: PF-07836391 Influenza saRNA; Intramuscular injection
Experimental: PF-07836391 Influenza saRNA, high dose	Biological: PF-07836391 Influenza saRNA; Intramuscular injection
Experimental: PF-07836394 Influenza saRNA, low dose	Biological: PF-07836394 Influenza saRNA; Intramuscular injection
Experimental: PF-07836394 Influenza saRNA, mid dose	Biological: PF-07836394 Influenza saRNA; Intramuscular injection
Experimental: PF-07836394 Influenza saRNA, high dose	Biological: PF-07836394 Influenza saRNA; Intramuscular injection
Experimental: PF-07836395 Influenza saRNA, low dose	Biological: PF-07836395 Influenza saRNA; Intramuscular injection
Experimental: PF-07836395 Influenza saRNA, mid dose	Biological: PF-07836395 Influenza saRNA; Intramuscular injection
Experimental: PF-07836395 Influenza saRNA, high dose	Biological: PF-07836395 Influenza saRNA; Intramuscular injection
Experimental: PF-07836396 Influenza saRNA, low dose	Biological: PF-07836396 Influenza saRNA; Intramuscular injection
Experimental: PF-07836396 Influenza saRNA, mid dose	Biological: PF-07836396 Influenza saRNA; Intramuscular injection
Experimental: PF-07836396 Influenza saRNA, high dose	Biological: PF-07836396 Influenza saRNA; Intramuscular injection
Experimental: PF-07867246 Influenza saRNA, mid dose	Biological: PF-07867246 Influenza saRNA; Intramuscular injection
Experimental: PF-07867246 Influenza saRNA, low dose	Biological: PF-07867246 Influenza saRNA; Intramuscular injection
Experimental: PF-07867246 Influenza saRNA, high dose	Biological: PF-07867246 Influenza saRNA; Intramuscular injection
Active Comparator: Quadrivalent influenza vaccine (QIV)	Biological: Quadrivalent influenza vaccine (QIV); Intramuscular injection
Experimental: PF-07871987 Influenza saRNA, low dose	Biological: PF-07871987 Influenza saRNA; Intramuscular injection
Experimental: PF-07871987 Influenza saRNA, mid dose	Biological: PF-07871987 Influenza saRNA; Intramuscular injection
Experimental: PF-07871987 Influenza saRNA, high dose	Biological: PF-07871987 Influenza saRNA; Intramuscular injection
Experimental: PF-07914705 Influenza saRNA mid dose	Biological: PF-07914705 Influenza saRNA; Intramuscular injection
Experimental: PF-07914705 Influenza saRNA, high dose	Biological: PF-07914705 Influenza saRNA; Intramuscular injection
Experimental: PF-07915048 Influenza saRNA, high dose	Biological: PF-07915048 Influenza saRNA; Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting local reactions	Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.	For 10 days after vaccination
Percentage of participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.	For 10 days after vaccination
Percentage of participants reporting adverse events	As elicited by investigational site staff.	From vaccination to 4 weeks after vaccination
Percentage of participants reporting serious adverse events	As elicited by investigational site staff.	From vaccination to 6 months after vaccination
Percentage of participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	2 days after vaccination
Percentage of participants with abnormal hematology and chemistry laboratory values	As measured at the central laboratory	1 week after vaccination
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory.	Between baseline and 2 days after vaccination
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments	As measured at the central laboratory	Between baseline and 1 week after vaccination
Percentage of participants with new electrocardiogram (ECG) abnormalities	ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist	2 days after vaccination
Percentage of participants with new ECG abnormalities	ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist	1 week after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers	As measured at the central laboratory	At Baseline, and 1-, 2- and 4-weeks after vaccination
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint	As measured at the central laboratory	At Baseline, and 1-, 2- and 4-weeks after vaccination
Proportion of participants achieving HAI seroconversion for each strain	As measured at the central laboratory	At 1-, 2-, and 4-weeks after vaccination
Proportion of participants with HAI titer >=1:40 for each strain	As measured at the central laboratory	At Baseline, and 1-, 2-, and 4-weeks after vaccination

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Flu; Grippe; RNA vaccine; Self-amplifying
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Antipruritics; Menthol; Camphor
• Other Study ID Numbers: C4861001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No