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

Phase 1

Completed

• Conditions: Influenza, Human
• Interventions: Biological: PF-07836394 Influenza saRNA; Biological: PF-07836396 Influenza saRNA; Biological: PF-07852352 Influenza saRNA 1; Biological: PF-07836395 Influenza saRNA; Biological: PF-07867246 Influenza saRNA; Biological: PF-07915048 Influenza saRNA; Biological: PF-07836391 Influenza saRNA; Biological: PF-07871987 Influenza saRNA; Biological: PF-07914705 Influenza saRNA; Biological: Placebo; Biological: Quadrivalent influenza vaccine (QIV)

• Registration Number: NCT05227001
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-07
• Study Start: 2022-04-28
• Primary Completion: 2023-08-04
• Study Completion: 2023-08-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PF-07836394 Influenza saRNA, low dose	PF-07836394 Influenza saRNA	-
PF-07836396 Influenza saRNA, low dose	PF-07836396 Influenza saRNA	-
PF-07852352 Influenza saRNA, high dose	PF-07852352 Influenza saRNA 1	-
PF-07836394 Influenza saRNA, mid dose	PF-07836394 Influenza saRNA	-
PF-07836394 Influenza saRNA, high dose	PF-07836394 Influenza saRNA	-
PF-07836395 Influenza saRNA, low dose	PF-07836395 Influenza saRNA	-
PF-07852352 Influenza saRNA, low dose	PF-07852352 Influenza saRNA 1	-
PF-07852352 Influenza saRNA, mid dose	PF-07852352 Influenza saRNA 1	-
PF-07836395 Influenza saRNA, mid dose	PF-07836395 Influenza saRNA	-
PF-07836396 Influenza saRNA, high dose	PF-07836396 Influenza saRNA	-
PF-07867246 Influenza saRNA, low dose	PF-07867246 Influenza saRNA	-
PF-07915048 Influenza saRNA, high dose	PF-07915048 Influenza saRNA	-
PF-07836391 Influenza saRNA, high dose	PF-07836391 Influenza saRNA	-
PF-07836391 Influenza saRNA, low dose	PF-07836391 Influenza saRNA	-
PF-07836391 Influenza saRNA, mid dose	PF-07836391 Influenza saRNA	-
PF-07867246 Influenza saRNA, high dose	PF-07867246 Influenza saRNA	-
PF-07871987 Influenza saRNA, low dose	PF-07871987 Influenza saRNA	-
PF-07871987 Influenza saRNA, high dose	PF-07871987 Influenza saRNA	-
PF-07914705 Influenza saRNA mid dose	PF-07914705 Influenza saRNA	-
PF-07836395 Influenza saRNA, high dose	PF-07836395 Influenza saRNA	-
PF-07836396 Influenza saRNA, mid dose	PF-07836396 Influenza saRNA	-
PF-07867246 Influenza saRNA, mid dose	PF-07867246 Influenza saRNA	-
Placebo	Placebo	-
Quadrivalent influenza vaccine (QIV)	Quadrivalent influenza vaccine (QIV)	-
PF-07871987 Influenza saRNA, mid dose	PF-07871987 Influenza saRNA	-
PF-07914705 Influenza saRNA, high dose	PF-07914705 Influenza saRNA	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (25)

Great Lakes Clinical Trials - Andersonville; 🇺🇸 Chicago, Illinois, United States

Pioneer Heart Institute; 🇺🇸 Lincoln, Nebraska, United States

Arizona Heart Rhythm Center; 🇺🇸 Phoenix, Arizona, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

The Pain Center of Arizona; 🇺🇸 Phoenix, Arizona, United States

Panax Clinical Research; 🇺🇸 Miami Lakes, Florida, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Comprehensive Cardiology Consultants; 🇺🇸 Pembroke Pines, Florida, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Benchmark Research; 🇺🇸 Austin, Texas, United States

Coastal Carolina Research Center; 🇺🇸 North Charleston, South Carolina, United States

Velocity Clinical Research, Omaha; 🇺🇸 Omaha, Nebraska, United States

Mount Sinai Hospital; 🇺🇸 Miami Beach, Florida, United States

Pinnacle Health Care Center; 🇺🇸 Pembroke Pines, Florida, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Finlay Medical Research; 🇺🇸 Greenacres City, Florida, United States

Miami Clinical Research; 🇺🇸 Miami, Florida, United States

Pines Care Research Center, LLC; 🇺🇸 Pembroke Pines, Florida, United States

SUNY Upstate Medical University Institute for Global Health; 🇺🇸 Syracuse, New York, United States

SUNY Upstate Medical University Global Health Laboratory; 🇺🇸 Syracuse, New York, United States

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Meridian Clinical Research, LLC; 🇺🇸 Omaha, Nebraska, United States

DM Clinical Research; 🇺🇸 Tomball, Texas, United States

Eric S. Tiblier, MD; 🇺🇸 Austin, Texas, United States