A Phase 3 interventional study of Influenza and COVID-19 Combination A and Licensed influenza vaccine in Influenza and COVID-19, sponsored by BioNTech SE. Completed at 106 sites in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by BioNTech SE · Phase 3, Interventional, and Prevention
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.
Cohort 1: Approximately 450 participants will be assigned by chance to one of the following:
Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following:
Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:
All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 8,795 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →BioNTech SE is the lead sponsor of 74 studies on the registry; 23 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Please refer to the study contact for further eligibility details
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Biological: Influenza and COVID-19 Combination A · Biological: Placebo
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Biological: Licensed influenza vaccine · Biological: COVID-19 Vaccine
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Biological: Influenza and COVID-19 Combination B · Biological: Placebo
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Biological: Licensed influenza vaccine · Biological: COVID-19 Vaccine
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Biological: Influenza and COVID-19 Combination B
Cohort 3 Arm F: COVID-19 vaccine
Biological: COVID-19 Vaccine
Cohort 3 Arm G: Licensed influenza vaccine
Biological: Licensed influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccine
Biological: Investigational influenza vaccine
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
Licensed influenza vaccine
Pfizer-BioNTech COVID-19 vaccine
Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Saline Solution
Investigational influenza vaccine
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
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.
Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
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.
Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day1]
Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
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.
Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
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.
Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
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.
Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
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.
Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination 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.
Time frame: From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 2: Percentage of Participants Reporting AEs From Vaccination 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.
Time frame: From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 3: Percentage of Participants Reporting AEs From Vaccination 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.
Time frame: From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination 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.
Time frame: From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination 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.
Time frame: From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 3: Percentage of Participants Reporting SAEs From Vaccination 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.
Time frame: From Vaccination on Day 1 through 6 Months after Vaccination
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
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.
Time frame: At 4 Weeks after Vaccination
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
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.
Time frame: At 4 Weeks after Vaccination
Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
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.
Time frame: At 4 Weeks after Vaccination
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority
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.
Time frame: At 4 Weeks after Vaccination
Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority
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. Data was reported for reported for following strains: H1N1, H3N2 and Victoria.
Time frame: At 4 Weeks after Vaccination
Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
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.
Time frame: At 4 Weeks after Vaccination
| Milestone | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|---|---|---|---|
| Started | 313 | 160 | 3142 | 1572 | 1197 | 1195 | 607 | 609 |
| Vaccinated | 309 | 159 | 3127 | 1563 | 1189 | 1191 | 605 | 607 |
| Completed | 304 | 148 | 2938 | 1468 | 1110 | 1125 | 571 | 583 |
| Not completed | 9 | 12 | 204 | 104 | 87 | 70 | 36 | 26 |
| Withdrew: Withdrawal by subject | 2 | 6 | 44 | 23 | 7 | 7 | 7 | 5 |
| Withdrew: Lost to follow-up | 2 | 4 | 133 | 65 | 68 | 57 | 25 | 18 |
| Withdrew: Death | 1 | 0 | 2 | 1 | 1 | 0 | 1 | 1 |
| Withdrew: Randomized but not vaccinated | 4 | 1 | 15 | 9 | 8 | 4 | 2 | 2 |
| Withdrew: Other: unspecified | 0 | 1 | 7 | 6 | 1 | 1 | 1 | 0 |
| Withdrew: Physician decision | 0 | 0 | 2 | 0 | 2 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
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.
| Percentage of participants | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 74.7 (69.4 to 79.4) | 59.1 (51.1 to 66.8) |
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.
| Percentage of participants | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 73.4 (71.8 to 75.0) | 63.5 (61.0 to 65.9) |
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.
| Percentage of participants | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|
| Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 73.4 (70.8 to 75.9) | 62.5 (59.6 to 65.2) | 34.8 (31.0 to 38.7) | 66.3 (62.4 to 70.1) |
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.
| Percentage of participants | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 71.8 (66.4 to 76.7) | 54.1 (46.0 to 62.0) |
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.
| Percentage of participants | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 70.8 (69.2 to 72.4) | 59.9 (57.4 to 62.3) |
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.
| Percentage of participants | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|
| Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 66.7 (63.9 to 69.4) | 52.1 (49.2 to 55.0) | 43.9 (39.9 to 47.9) | 61.1 (57.0 to 65.0) |
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.
| Percentage of participants | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 5.8 (3.5 to 9.1) | 10.1 (5.9 to 15.8) |
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.
| Percentage of participants | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 6.4 (5.6 to 7.3) | 6.1 (4.9 to 7.4) |
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.
| Percentage of participants | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|
| Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 3.8 (2.8 to 5.0) | 4.8 (3.6 to 6.2) | 4.1 (2.7 to 6.0) | 4.1 (2.7 to 6.0) |
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.
| Percentage of participants | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.6 (0.1 to 2.3) | 2.5 (0.7 to 6.3) |
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.
| Percentage of participants | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.7 (0.5 to 1.1) | 1.4 (0.9 to 2.1) |
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.
| Percentage of participants | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|
| Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.8 (0.4 to 1.5) | 1.3 (0.7 to 2.1) | 0.8 (0.3 to 1.9) | 1.2 (0.5 to 2.4) |
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.
| Titer | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| H1N1 | 188.3 (178.2 to 198.9) | 136.3 (125.9 to 147.5) |
| H3N2 | 165.9 (158.0 to 174.1) | 96.9 (90.6 to 103.5) |
| Victoria | 37.4 (35.5 to 39.5) | 56.4 (52.4 to 60.6) |
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.
| Percentage of participants | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| H1N1 | 72.8 (70.7 to 74.8) | 54.9 (51.7 to 58.1) |
| H3N2 | 65.7 (63.5 to 67.8) | 40.1 (36.9 to 43.3) |
| Victoria | 31.7 (29.6 to 33.8) | 45.4 (42.2 to 48.6) |
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.
| Titer | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority | 3535.1 (3370.0 to 3708.4) | 3476.6 (3256.7 to 3711.4) |
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.
| Percentage of participants | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration |
|---|---|---|
| Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority | 75.5 (73.9 to 77.1) | 73.7 (71.4 to 76.0) |
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. Data was reported for reported for following strains: H1N1, H3N2 and Victoria.
| Titer | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|
| H1N1 | 165.6 (153.5 to 178.7) | 142.5 (126.9 to 160.0) | 170.2 (153.2 to 189.2) |
| H3N2 | 175.7 (165.3 to 186.8) | 100.1 (90.9 to 110.3) | 190.4 (173.4 to 209.2) |
| Victoria | 39.2 (36.6 to 42.1) | 67.4 (61.1 to 74.3) | 31.5 (28.6 to 34.6) |
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.
| Titer | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine |
|---|---|---|
| Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority | 3841.0 (3577.3 to 4124.1) | 4208.9 (3901.8 to 4540.2) |
Collected over Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 1/309 (0.3%) | 2/309 (0.6%) | 245/309 (79.3%) |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 0/159 (0%) | 4/159 (2.5%) | 113/159 (71.1%) |
| Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | 2/3,127 (0.1%) | 23/3,127 (0.7%) | 2,521/3,127 (80.6%) |
| Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 1/1,563 (0.1%) | 22/1,563 (1.4%) | 1,152/1,563 (73.7%) |
| Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | 1/1,189 (0.1%) | 10/1,189 (0.8%) | 941/1,189 (79.1%) |
| Cohort 3, Arm F: COVID-19 Vaccine | 0/1,191 (0%) | 15/1,191 (1.3%) | 843/1,191 (70.8%) |
| Cohort 3, Arm G: Licensed Influenza Vaccine | 1/605 (0.2%) | 5/605 (0.8%) | 330/605 (54.5%) |
| Cohort 3, Arm H: Investigational Influenza Vaccine | 1/607 (0.2%) | 7/607 (1.2%) | 456/607 (75.1%) |
| Event | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|---|---|---|---|
| Diabetic foot infectionInfections and infestations | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Renal abscessInfections and infestations | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Septic shockInfections and infestations | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Upper limb fractureInjury, poisoning and procedural complications | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Metastatic renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Extremity necrosisVascular disorders | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Hypertensive crisisVascular disorders | 0/309 | 1/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| Meningitis bacterialInfections and infestations | 1/309 | 0/159 | 0/3127 | 0/1563 | 0/1189 | 0/1191 | 0/605 | 0/607 |
| SeizureNervous system disorders | 1/309 | 0/159 | 0/3127 | 2/1563 | 0/1189 | 0/1191 | 0/605 | 1/607 |
| OsteomyelitisInfections and infestations | 0/309 | 0/159 | 1/3127 | 0/1563 | 0/1189 | 2/1191 | 0/605 | 0/607 |
| Event | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine |
|---|---|---|---|---|---|---|---|---|
| Injection site pain (PAIN)General disorders | 227/309 | 93/159 | 2259/3127 | 976/1563 | 861/1189 | 732/1191 | 199/605 | 396/607 |
| Fatigue (FATIGUE)General disorders | 180/309 | 66/159 | 1780/3127 | 705/1563 | 610/1189 | 448/1191 | 186/605 | 289/607 |
| Headache (HEADACHE)Nervous system disorders | 147/309 | 47/159 | 1403/3127 | 517/1563 | 489/1189 | 343/1191 | 145/605 | 197/607 |
| Chills (CHILLS)General disorders | 117/309 | 26/159 | 1163/3127 | 295/1563 | 327/1189 | 144/1191 | 40/605 | 133/607 |
| Myalgia (MUSCLE PAIN)Musculoskeletal and connective tissue disorders | 114/309 | 23/159 | 1081/3127 | 368/1563 | 356/1189 | 214/1191 | 62/605 | 167/607 |
| Arthralgia (JOINT PAIN)Musculoskeletal and connective tissue disorders | 77/309 | 18/159 | 640/3127 | 212/1563 | 220/1189 | 128/1191 | 45/605 | 94/607 |
| Diarrhoea (DIARRHEA)Gastrointestinal disorders | 45/309 | 22/159 | 446/3127 | 207/1563 | 164/1189 | 140/1191 | 64/605 | 77/607 |
| Injection site erythema (REDNESS)General disorders | 44/309 | 11/159 | 293/3127 | 103/1563 | 122/1189 | 84/1191 | 18/605 | 46/607 |
| Pyrexia (FEVER)General disorders | 43/309 | 4/159 | 331/3127 | 71/1563 | 123/1189 | 30/1191 | 6/605 | 35/607 |
| Injection site swelling (SWELLING)General disorders | 40/309 | 12/159 | 376/3127 | 122/1563 | 151/1189 | 101/1191 | 20/605 | 62/607 |
Baseline analysis population was evaluated on safety population which included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
| Age, Continuous(Years) | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 44.2 ± 12.13 | 44.7 ± 13.89 | 44.0 ± 12.91 | 44.2 ± 12.53 | 44.3 ± 12.72 | 45.3 ± 12.45 | 44.5 ± 12.69 | 45.1 ± 12.82 | 44.4 ± 12.73 |
| Sex: Female, Male(Participants) | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 180 | 95 | 1740 | 848 | 654 | 683 | 336 | 332 | 4868 |
| Male | 129 | 64 | 1387 | 715 | 535 | 508 | 269 | 275 | 3882 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 105 | 51 | 966 | 491 | 457 | 435 | 224 | 225 | 2954 |
| Not Hispanic or Latino | 201 | 108 | 2145 | 1055 | 719 | 739 | 372 | 371 | 5710 |
| Unknown or Not Reported | 3 | 0 | 16 | 17 | 13 | 17 | 9 | 11 | 86 |
| Race (NIH/OMB)(Participants) | Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo | Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) | Cohort 3, Arm F: COVID-19 Vaccine | Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3, Arm H: Investigational Influenza Vaccine | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 22 | 17 | 13 | 4 | 4 | 2 | 63 |
| Asian | 4 | 6 | 111 | 58 | 35 | 34 | 18 | 20 | 286 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 12 | 2 | 9 | 3 | 2 | 2 | 31 |
| Black or African American | 74 | 37 | 812 | 392 | 277 | 295 | 143 | 157 | 2187 |
| White | 227 | 111 | 2106 | 1051 | 830 | 842 | 425 | 419 | 6011 |
| More than one race | 1 | 2 | 32 | 24 | 15 | 7 | 7 | 2 | 90 |
| Unknown or Not Reported | 2 | 2 | 32 | 19 | 10 | 6 | 6 | 5 | 82 |
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