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Quadrivalent influenza modRNA vaccine

Phase 3

Influenza, Human | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: May 8, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment45,789
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05540522A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or OlderPHASE3 COMPLETED 45,789Sep 12, 2022Mar 12, 2024May 8, 2025321 United States, Argentina +4
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Study Endpoints
Primary Endpoints
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
Day 15 to surveillance cut-off (approximately 6 months)

LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years
Day 15 up to primary surveillance cut-off (approximately 1 year)

LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years
From Day 1 to Day 7 after study vaccination

Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.

Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years
From Day 1 to Day 7 after study vaccination

Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.

Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years
From Day 1 to Day 7 after study vaccination

Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.

Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years
From Day 1 to Day 7 after study vaccination

Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.

Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years
From study vaccination on Day 1 through 4 weeks after study vaccination

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.

Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years
From study vaccination on Day 1 through 4 weeks after study vaccination

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.

Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years
From study vaccination on Day 1 through 4 weeks after study vaccination

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.

Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years
From Day 1 up to 6 months after vaccination

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.

Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years
From Day 1 up to 6 months after vaccination

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.

Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years
From Day 1 up to 6 months after vaccination

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.

Secondary Endpoints
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
Day 15 to surveillance cut-off (approximately 6 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Quadrivalent influenza modRNA vaccine, 18 through 64 years of ageEXPERIMENTALQuadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age
Quadrivalent influenza vaccine, 18 through 64 years of ageACTIVE_COMPARATORLicensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age
Quadrivalent influenza modRNA vaccine, ≥65 years of ageEXPERIMENTALQuadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age
Quadrivalent influenza vaccine, ≥65 years of ageACTIVE_COMPARATORLicensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age
Interventions
NameTypeDescription
Quadrivalent influenza modRNA vaccineBIOLOGICALQuadrivalent influenza modRNA vaccine (single dose)
Quadrivalent influenza vaccineBIOLOGICALLicensed quadrivalent influenza vaccine (single dose)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites321

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 determi...

Countries:United StatesArgentinaChileNew ZealandPhilippinesSouth Africa
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