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PF-07852352 Influenza saRNA 1

Phase 1

Influenza, Human | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 20, 2026

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
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment440
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05227001A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of InfluenzaPHASE1 COMPLETED 440Apr 28, 2022Aug 4, 2023Mar 20, 202624 United States
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Study Endpoints
Primary Endpoints
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 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 adverse events
From vaccination to 4 weeks after vaccination

As elicited by investigational site staff.

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
2 days after vaccination

As measured at the central laboratory

Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
Between baseline and 2 days 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

Secondary Endpoints
Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
At Baseline, and 1-, 2- and 4-weeks after vaccination
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
Proportion of participants achieving HAI seroconversion for each strain
At 1-, 2-, and 4-weeks after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PF-07852352 Influenza saRNA, low doseEXPERIMENTAL -
PF-07852352 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07852352 Influenza saRNA, high doseEXPERIMENTAL -
PF-07836391 Influenza saRNA, low doseEXPERIMENTAL -
PF-07836391 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07836391 Influenza saRNA, high doseEXPERIMENTAL -
PF-07836394 Influenza saRNA, low doseEXPERIMENTAL -
PF-07836394 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07836394 Influenza saRNA, high doseEXPERIMENTAL -
PF-07836395 Influenza saRNA, low doseEXPERIMENTAL -
PF-07836395 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07836395 Influenza saRNA, high doseEXPERIMENTAL -
PF-07836396 Influenza saRNA, low doseEXPERIMENTAL -
PF-07836396 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07836396 Influenza saRNA, high doseEXPERIMENTAL -
PF-07867246 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07867246 Influenza saRNA, low doseEXPERIMENTAL -
PF-07867246 Influenza saRNA, high doseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Quadrivalent influenza vaccine (QIV)ACTIVE_COMPARATOR -
PF-07871987 Influenza saRNA, low doseEXPERIMENTAL -
PF-07871987 Influenza saRNA, mid doseEXPERIMENTAL -
PF-07871987 Influenza saRNA, high doseEXPERIMENTAL -
PF-07914705 Influenza saRNA mid doseEXPERIMENTAL -
PF-07914705 Influenza saRNA, high doseEXPERIMENTAL -
PF-07915048 Influenza saRNA, high doseEXPERIMENTAL -
Interventions
NameTypeDescription
PF-07852352 Influenza saRNA 1BIOLOGICALIntramuscular injection
PF-07836391 Influenza saRNABIOLOGICALIntramuscular injection
PF-07836394 Influenza saRNABIOLOGICALIntramuscular injection
PF-07836395 Influenza saRNABIOLOGICALIntramuscular injection
PF-07836396 Influenza saRNABIOLOGICALIntramuscular injection
PF-07867246 Influenza saRNABIOLOGICALIntramuscular injection
PlaceboBIOLOGICALIntramuscular injection
Quadrivalent influenza vaccine (QIV)BIOLOGICALIntramuscular injection
PF-07871987 Influenza saRNABIOLOGICALIntramuscular injection
PF-07914705 Influenza saRNABIOLOGICALIntramuscular injection
PF-07915048 Influenza saRNABIOLOGICALIntramuscular injection
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites24

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,...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 21, 2026NCT05227001TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT05227001TRIAL_REMOVED: changed