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pdmFlu vaccine

Phase 1

Grippe | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Feb 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment157
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06179446A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic InfluenzaPHASE1 COMPLETED 157 — — Dec 13, 2023Sep 23, 2025Feb 23, 20263 United States
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Study Endpoints
Primary Endpoints
Percentage of participants by age group reporting local reactions
For 7 days after vaccination
Percentage of participants by age group reporting systemic events
For 7 days after vaccination
Percentage of participants by age group reporting adverse events
From vaccination to 4 weeks after each vaccination
Percentage of participants by age group reporting serious adverse events
From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
Percentage of participants by age group reporting medically attended adverse events
From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
Percentage of participants by age group with abnormal hematology and chemistry laboratory values
1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments
Between baseline and 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with new clinically significant ECG abnormalities
1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with new troponin I abnormalities
1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Secondary Endpoints
Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination
Proportion of participants by age group achieving HAI seroconversion
At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
pdmFlu vaccine 1EXPERIMENTAL -
pdmFlu vaccine 2EXPERIMENTAL -
pdmFlu vaccine 3EXPERIMENTAL -
pdmFlu vaccine 4EXPERIMENTAL -
pdmFlu vaccine 5EXPERIMENTAL -
pdmFlu vaccine 6EXPERIMENTAL -
pdmFlu vaccine 7EXPERIMENTAL -
pdmFlu vaccine 8EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Licensed influenza vaccineACTIVE_COMPARATOR -
Interventions
NameTypeDescription
pdmFlu vaccineBIOLOGICALIntramuscular injection
PlaceboBIOLOGICALIntramuscular injection
Licensed influenza vaccineBIOLOGICALIntramuscular injection
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Eligibility Criteria
Age Range18 Years — 84 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria: \- 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. Key Exclusion Criteria: \- Does not meet seasonal influenza vaccine requirements per coho...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMApr 8, 2026NCT06179446TRIAL_REMOVED: changed
MEDIUMApr 8, 2026NCT06179446TRIAL_REMOVED: changed