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Influenza and COVID-19 Combination A

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Dec 4, 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 Enrollment8,795
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06178991A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.PHASE3 COMPLETED 8,795Dec 20, 2023Nov 26, 2024Dec 4, 2025106 United States
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Study Endpoints
Primary Endpoints
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.

Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
From Day 1 through Day 7 after Vaccination [Vaccination on Day1]

Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.

Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.

Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.

Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.

Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.

Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
From Vaccination on Day 1 through 4 Weeks after 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. AEs included both serious and all non-serious AEs. Serious AE (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, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
From Vaccination on Day 1 through 4 Weeks after 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. AEs included both serious and all non-serious AEs. 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, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
From Vaccination on Day 1 through 4 Weeks after 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. AEs included both serious and all non-serious AEs. 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, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
From Vaccination on Day 1 through 6 Months after Vaccination

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, and any other pre-specified criteria in protocol of the study or other important medical event.

Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
From Vaccination on Day 1 through 6 Months after Vaccination

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, and any other pre-specified criteria in protocol of the study or other important medical event.

Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
From Vaccination on Day 1 through 6 Months after Vaccination

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, and any other pre-specified criteria in protocol of the study or other important medical event.

Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination

GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.

Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination

Seroconversion was defined as having an HAI titer \<1:10 prior to vaccination and greater than or equal to (\>=) 1:40 at the postvaccination time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.

Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.

Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination

Seroresponse was defined as achieving a postvaccination \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>=4\*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section.

Secondary Endpoints
Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination
Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Cohort 1 Arm A: Influenza and COVID-19 Combination A and PlaceboEXPERIMENTALCohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration groupACTIVE_COMPARATORCohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 2 Arm C:Influenza and COVID-19 Combination B and PlaceboEXPERIMENTALCohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration groupACTIVE_COMPARATORCohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 3 Arm E:Influenza and COVID-19 Combination BEXPERIMENTALCohort 3 Arm E:Influenza and COVID-19 Combination B
Cohort 3 Arm F: COVID-19 vaccineACTIVE_COMPARATORCohort 3 Arm F: COVID-19 vaccine
Cohort 3 Arm G: Licensed influenza vaccineACTIVE_COMPARATORCohort 3 Arm G: Licensed influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccineACTIVE_COMPARATORCohort 3 Arm H: Investigational influenza vaccine
Interventions
NameTypeDescription
Influenza and COVID-19 Combination ABIOLOGICALCombined influenza and Pfizer-BioNTech COVID-19 Vaccine
Licensed influenza vaccineBIOLOGICALLicensed influenza vaccine
COVID-19 VaccineBIOLOGICALPfizer-BioNTech COVID-19 vaccine
Influenza and COVID-19 Combination BBIOLOGICALCombined influenza and Pfizer-BioNTech COVID-19 vaccine
PlaceboBIOLOGICALSaline Solution
Investigational influenza vaccineBIOLOGICALInvestigational influenza vaccine
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites106

Inclusion Criteria: * Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible f...

Countries:United States
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