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Completed

NCT Number: NCT05227001

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 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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Heart Rhythm Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07852352 Influenza saRNA 1

Biological

Intramuscular injection

PF-07836391 Influenza saRNA

Biological

Intramuscular injection

PF-07836394 Influenza saRNA

Biological

Intramuscular injection

PF-07836395 Influenza saRNA

Biological

Intramuscular injection

PF-07836396 Influenza saRNA

Biological

Intramuscular injection

PF-07867246 Influenza saRNA

Biological

Intramuscular injection

Placebo

Biological

Intramuscular injection

Quadrivalent Influenza Vaccine (QIV)

Biological

Intramuscular injection

PF-07871987 Influenza saRNA

Biological

Intramuscular injection

PF-07914705 Influenza saRNA

Biological

Intramuscular injection

PF-07915048 Influenza saRNA

Biological

Intramuscular injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2022
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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