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A Study to Evaluate a Modifie...

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older

Last Updated: 2025-05-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45789 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2024-03-12

Brief Summary

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This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.

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Detailed Description

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This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 seasonally recommended strains (2 A strains and 2 B strains) compared to licensed quadrivalent influenza vaccine (QIV) in healthy adults 18 years of age and older.

Participants may be enrolled in either the reactogenicity subset, immunogenicity subset, or both/neither subset(s). Efficacy will be assessed in this study through surveillance for influenza-like illness.

Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Study Groups

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Quadrivalent influenza modRNA vaccine, 18 through 64 years of age

Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age

Group Type EXPERIMENTAL

Quadrivalent influenza modRNA vaccine

Intervention Type BIOLOGICAL

Quadrivalent influenza modRNA vaccine (single dose)

Quadrivalent influenza vaccine, 18 through 64 years of age

Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age

Group Type ACTIVE_COMPARATOR

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

Licensed quadrivalent influenza vaccine (single dose)

Quadrivalent influenza modRNA vaccine, ≥65 years of age

Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age

Group Type EXPERIMENTAL

Quadrivalent influenza modRNA vaccine

Intervention Type BIOLOGICAL

Quadrivalent influenza modRNA vaccine (single dose)

Quadrivalent influenza vaccine, ≥65 years of age

Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age

Group Type ACTIVE_COMPARATOR

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

Licensed quadrivalent influenza vaccine (single dose)

Interventions

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Quadrivalent influenza modRNA vaccine

Quadrivalent influenza modRNA vaccine (single dose)

Intervention Type BIOLOGICAL

Quadrivalent influenza vaccine

Licensed quadrivalent influenza vaccine (single dose)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Male or female participants ≥18 years of age at Visit 1 (Day 1).
2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
3. 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.
4. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria

1. 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.
2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
3. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
5. Allergy to egg proteins (egg or egg products) or chicken proteins.
6. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
7. Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study.
8. Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
9. Any participant who has received or plans to receive a modRNA-platform SARS CoV-2 vaccine within 14 days before or after study vaccination at Visit 1.
10. Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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North Alabama Research Center

Athens, Alabama, United States

Site Status

St. Vincent's Birmingham Hospital

Birmingham, Alabama, United States

Site Status

Accel Research Sites Network - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Site Status

Ross Bridge Medical Practice, LLC-CCT Research

Birmingham, Alabama, United States

Site Status

SEC Clinical Research

Dothan, Alabama, United States

Site Status

Lakeview Clinical Research

Guntersville, Alabama, United States

Site Status

Medical Affiliated Research Center

Huntsville, Alabama, United States

Site Status

Lenzmeier Family Medicine/CCT Research

Glendale, Arizona, United States

Site Status

Aventiv Research

Mesa, Arizona, United States

Site Status