NCT05540522

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

A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA COMPARED TO LICENSED INACTIVATED INFLUENZA VACCINE IN HEALTHY ADULTS 18 YEARS OF AGE OR OLDER

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45,789 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent influenza modRNA vaccine	Quadrivalent influenza modRNA vaccine (single dose)
BIOLOGICAL	Quadrivalent influenza vaccine	Licensed quadrivalent influenza vaccine (single dose)

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-03-12
• Completion: 2024-03-12
• First posted: 2022-09-14
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

321 sites across 6 countries: United States, Argentina, Chile, New Zealand, Philippines, South Africa

Regulatory

• FDA-regulated drug study