We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05227001
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza, Human 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: Placebo Biological: Quadrivalent influenza vaccine (QIV) Biological: PF-07871987 Influenza saRNA Biological: PF-07914705 Influenza saRNA Biological: PF-07915048 Influenza saRNA Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
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

Placebo Comparator: Placebo Biological: Placebo
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




Primary Outcome Measures :
  1. Percentage of participants reporting local reactions [ Time Frame: For 10 days after vaccination ]
    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.

  2. Percentage of participants reporting systemic events [ Time Frame: For 10 days after vaccination ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.

  3. Percentage of participants reporting adverse events [ Time Frame: From vaccination to 4 weeks after vaccination ]
    As elicited by investigational site staff.

  4. Percentage of participants reporting serious adverse events [ Time Frame: From vaccination to 6 months after vaccination ]
    As elicited by investigational site staff.

  5. Percentage of participants with abnormal hematology and chemistry laboratory values [ Time Frame: 2 days after vaccination ]
    As measured at the central laboratory

  6. Percentage of participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 week after vaccination ]
    As measured at the central laboratory

  7. Percentage of participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 2 days after vaccination ]
    As measured at the central laboratory.

  8. Percentage of participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 week after vaccination ]
    As measured at the central laboratory

  9. Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 2 days after vaccination ]
    ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist

  10. Percentage of participants with new ECG abnormalities [ Time Frame: 1 week after vaccination ]
    ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist


Secondary Outcome Measures :
  1. Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers [ Time Frame: At Baseline, and 1-, 2- and 4-weeks after vaccination ]
    As measured at the central laboratory

  2. Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint [ Time Frame: At Baseline, and 1-, 2- and 4-weeks after vaccination ]
    As measured at the central laboratory

  3. Proportion of participants achieving HAI seroconversion for each strain [ Time Frame: At 1-, 2-, and 4-weeks after vaccination ]
    As measured at the central laboratory

  4. Proportion of participants with HAI titer >=1:40 for each strain [ Time Frame: At Baseline, and 1-, 2-, and 4-weeks after vaccination ]
    As measured at the central laboratory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05227001


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 24 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05227001    
Other Study ID Numbers: C4861001
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Grippe
Flu
Influenza
Vaccine
RNA vaccine
Self-amplifying
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Camphor
Menthol
Anti-Infective Agents, Local
Anti-Infective Agents
Antipruritics
Dermatologic Agents