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Investigational Influenza Vaccine

Phase 1

Influenza,Human | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Aug 15, 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 Enrollment1,353
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06683352A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy PeoplePHASE1 COMPLETED 1,353Nov 11, 2024Jul 15, 2025Aug 15, 202522 United States
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Study Endpoints
Primary Endpoints
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Day 7

Describe prompted local reactions following investigational product administration

Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Day 7

Describe prompted systemic events following investigational product administration

Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
4 weeks after vaccination

Describe AEs occurring through 4 weeks following administration of investigational product

Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
6 months after vaccination

Describe SAEs through 6 months following administration of investigational product

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALCOVID-19 Vaccine (Dose 1) and Placebo
Arm BEXPERIMENTALCOVID-19 Vaccine (Dose 2) and Placebo
Arm CACTIVE_COMPARATORCOVID-19 Vaccine (Dose 3) and Placebo
Arm DEXPERIMENTALInvestigational Influenza Vaccine (Dose 1) and Placebo
Arm EACTIVE_COMPARATORLicensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)
Arm EEACTIVE_COMPARATORLicensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)
Arm FEXPERIMENTALInvestigational Influenza Vaccine (Dose 2) and Placebo
Arm GEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 1) and Placebo
Arm HEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 2) and Placebo
Arm IEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 3) and Placebo
Arm JEXPERIMENTALInvestigational Influenza Vaccine (Dose 3) and Placebo
Arm KEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 4) and Placebo
Arm LEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 5) and Placebo
Arm MEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 6) and Placebo
Arm NEXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 7) and Placebo
Interventions
NameTypeDescription
Investigational Influenza VaccineBIOLOGICALInvestigational Influenza Vaccine
COVID-19 VaccineBIOLOGICALPfizer-BioNTech COVID-19 Vaccine
Influenza and COVID Combination VaccineCOMBINATION_PRODUCTCombined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Licensed Influenza Vaccine 1BIOLOGICALLicensed Influenza Vaccine 1
Licensed Influenza Vaccine 2BIOLOGICALLicensed Influenza Vaccine 2
PlaceboOTHERSaline
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites22

Inclusion Criteria: * Participants 18 years of age or older * Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria: * Vaccination with any ...

Countries:United States
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