A Phase 1/2 interventional study of Investigational Influenza Vaccine and COVID-19 Vaccine in Influenza,Human and COVID-19, sponsored by BioNTech SE. Completed at 22 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by BioNTech SE · Phase 1/2, Interventional, and Prevention
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 1,353 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.
Low Dose COVID-19 Vaccine and Placebo
Biological: COVID-19 Vaccine · Other: Placebo
Medium Dose COVID-19 Vaccine and Placebo
Biological: COVID-19 Vaccine · Other: Placebo
High Dose COVID-19 Vaccine and Placebo
Biological: COVID-19 Vaccine · Other: Placebo
Low Dose Investigational Influenza Vaccine and Placebo
Biological: Investigational Influenza Vaccine · Other: Placebo
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
Biological: COVID-19 Vaccine · Biological: Licensed Influenza Vaccine 1
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
Biological: COVID-19 Vaccine · Biological: Licensed Influenza Vaccine 2
Medium Dose Investigational Influenza Vaccine and Placebo
Biological: Investigational Influenza Vaccine · Other: Placebo
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
High Dose Investigational Influenza Vaccine and Placebo
Biological: Investigational Influenza Vaccine · Other: Placebo
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
Combination Product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo
Investigational Influenza Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Licensed Influenza Vaccine 1
Licensed Influenza Vaccine 2
Saline
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
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
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: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the 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: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the 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 1 Month 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 1 month after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month 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 1 month after Vaccination [Vaccination on Day 1]
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. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
Time frame: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
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. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
Time frame: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
There were 2 cohorts in the study: Cohort 1 enrolled participants 18 to 64 years of age and Cohort 2 enrolled participants \>=65 years of age.
| Milestone | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 51 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 51 | 50 | 50 | 50 | 50 | 50 | 50 | 51 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| Vaccinated | 51 | 50 | 49 | 50 | 50 | 50 | 50 | 50 | 49 | 49 | 51 | 50 | 50 | 50 | 50 | 50 | 49 | 50 | 50 | 50 | 50 | 50 | 49 | 50 | 50 | 50 | 50 |
| Completed | 49 | 49 | 49 | 47 | 48 | 48 | 47 | 48 | 48 | 43 | 50 | 48 | 50 | 45 | 48 | 50 | 48 | 46 | 48 | 49 | 49 | 49 | 47 | 48 | 48 | 49 | 48 |
| Not completed | 2 | 1 | 1 | 3 | 2 | 2 | 3 | 2 | 2 | 7 | 1 | 2 | 0 | 5 | 2 | 0 | 2 | 5 | 2 | 1 | 1 | 1 | 3 | 2 | 2 | 1 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 | 0 | 2 | 1 | 3 | 2 | 0 | 5 | 0 | 2 | 0 | 4 | 1 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Other: unspecified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Randomized but not vaccinated | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 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: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination | 50.0 (35.5 to 64.5) | 61.2 (46.2 to 74.8) | 65.3 (50.4 to 78.3) | 80.0 (66.3 to 90.0) | 42.0 (28.2 to 56.8) | 70.0 (55.4 to 82.1) | 74.0 (59.7 to 85.4) | 72.0 (57.5 to 83.8) | 79.6 (65.7 to 89.8) | 89.6 (77.3 to 96.5) | 78.4 (64.7 to 88.7) | 86.0 (73.3 to 94.2) | 69.4 (54.6 to 81.7) | 90.0 (78.2 to 96.7) |
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 AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination | 30.0 (17.9 to 44.6) | 42.0 (28.2 to 56.8) | 42.9 (28.8 to 57.8) | 64.0 (49.2 to 77.1) | 36.7 (23.4 to 51.7) | 58.0 (43.2 to 71.8) | 66.0 (51.2 to 78.8) | 63.3 (48.3 to 76.6) | 66.7 (51.6 to 79.6) | 60.0 (45.2 to 73.6) | 68.0 (53.3 to 80.5) | 60.0 (45.2 to 73.6) | 67.3 (52.5 to 80.1) |
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the 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: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 64.0 (49.2 to 77.1) | 57.1 (42.2 to 71.2) | 49.0 (34.4 to 63.7) | 72.0 (57.5 to 83.8) | 44.0 (30.0 to 58.7) | 68.0 (53.3 to 80.5) | 68.0 (53.3 to 80.5) | 68.0 (53.3 to 80.5) | 77.6 (63.4 to 88.2) | 70.8 (55.9 to 83.0) | 70.6 (56.2 to 82.5) | 78.0 (64.0 to 88.5) | 73.5 (58.9 to 85.1) | 76.0 (61.8 to 86.9) |
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the 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 AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 34.0 (21.2 to 48.8) | 38.0 (24.7 to 52.8) | 40.8 (27.0 to 55.8) | 62.0 (47.2 to 75.3) | 40.8 (27.0 to 55.8) | 36.0 (22.9 to 50.8) | 62.0 (47.2 to 75.3) | 49.0 (34.4 to 63.7) | 56.3 (41.2 to 70.5) | 46.0 (31.8 to 60.7) | 56.0 (41.3 to 70.0) | 46.0 (31.8 to 60.7) | 57.1 (42.2 to 71.2) |
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: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination | 3.9 (0.5 to 13.5) | 2.0 (0.1 to 10.6) | 6.1 (1.3 to 16.9) | 2.0 (0.1 to 10.6) | 10.0 (3.3 to 21.8) | 4.0 (0.5 to 13.7) | 8.0 (2.2 to 19.2) | 2.0 (0.1 to 10.6) | 10.2 (3.4 to 22.2) | 10.2 (3.4 to 22.2) | 5.9 (1.2 to 16.2) | 6.0 (1.3 to 16.5) | 8.0 (2.2 to 19.2) | 6.0 (1.3 to 16.5) |
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 AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination | 8.0 (2.2 to 19.2) | 12.0 (4.5 to 24.3) | 12.2 (4.6 to 24.8) | 2.0 (0.1 to 10.6) | 6.0 (1.3 to 16.5) | 4.0 (0.5 to 13.7) | 6.0 (1.3 to 16.5) | 8.0 (2.2 to 19.2) | 4.1 (0.5 to 14.0) | 2.0 (0.1 to 10.6) | 4.0 (0.5 to 13.7) | 12.0 (4.5 to 24.3) | 8.0 (2.2 to 19.2) |
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. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
| Percentage of participants | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0 (0.0 to 7.0) | 2.0 (0.1 to 10.6) | 0 (0.0 to 7.3) | 2.0 (0.1 to 10.6) | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) | 2.0 (0.1 to 10.9) | 0 (0.0 to 7.3) | 0 (0.0 to 7.0) | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) | 2.0 (0.1 to 10.6) |
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. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
| Percentage of participants | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) | 6.1 (1.3 to 16.9) | 4.0 (0.5 to 13.7) | 0 (0.0 to 7.1) | 2.0 (0.1 to 10.6) | 2.0 (0.1 to 10.6) | 0 (0.0 to 7.1) | 2.0 (0.1 to 10.9) | 2.0 (0.1 to 10.6) | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) | 0 (0.0 to 7.1) |
Collected over Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: 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 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | 0/51 (0%) | 0/51 (0%) | 34/51 (66.7%) |
| Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 1/50 (2%) | 35/50 (70%) |
| Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | 0/49 (0%) | 0/49 (0%) | 33/49 (67.3%) |
| Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | 0/50 (0%) | 1/50 (2%) | 43/50 (86%) |
| Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | 0/50 (0%) | 0/50 (0%) | 26/50 (52%) |
| Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 39/50 (78%) |
| Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 41/50 (82%) |
| Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 40/50 (80%) |
| Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | 0/49 (0%) | 1/49 (2%) | 42/49 (85.7%) |
| Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | 0/49 (0%) | 0/49 (0%) | 45/49 (91.8%) |
| Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | 0/51 (0%) | 0/51 (0%) | 40/51 (78.4%) |
| Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 45/50 (90%) |
| Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 40/50 (80%) |
| Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 1/50 (2%) | 45/50 (90%) |
| Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 25/50 (50%) |
| Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 31/50 (62%) |
| Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | 0/49 (0%) | 3/49 (6.1%) | 29/49 (59.2%) |
| Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | 1/50 (2%) | 2/50 (4%) | 37/50 (74%) |
| Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | 0/50 (0%) | 0/50 (0%) | 29/50 (58%) |
| Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | 0/50 (0%) | 1/50 (2%) | 33/50 (66%) |
| Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 1/50 (2%) | 38/50 (76%) |
| Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 35/50 (70%) |
| Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | 0/49 (0%) | 1/49 (2%) | 39/49 (79.6%) |
| Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | 1/50 (2%) | 1/50 (2%) | 35/50 (70%) |
| Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | 0/50 (0%) | 0/50 (0%) | 39/50 (78%) |
| Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 30/50 (60%) |
| Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | 0/50 (0%) | 0/50 (0%) | 36/50 (72%) |
| Event | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chest painGeneral disorders | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| BacteraemiaInfections and infestations | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Escherichia pyelonephritisInfections and infestations | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| PneumoniaInfections and infestations | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| SepsisInfections and infestations | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Lumbar radiculopathyNervous system disorders | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Acute kidney injuryRenal and urinary disorders | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 1/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Coronary artery diseaseCardiac disorders | 0/51 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/49 | 0/51 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 1/50 | 0/50 | 0/50 | 0/49 | 0/50 | 0/50 | 0/50 | 0/50 |
| Event | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection site pain (PAIN)General disorders | 25/51 | 30/50 | 32/49 | 40/50 | 20/50 | 35/50 | 36/50 | 36/50 | 39/49 | 43/49 | 40/51 | 43/50 | 34/50 | 44/50 | 15/50 | 21/50 | 20/49 | 31/50 | 16/50 | 28/50 | 33/50 | 29/50 | 30/49 | 30/50 | 33/50 | 29/50 | 33/50 |
| Fatigue (FATIGUE)General disorders | 24/51 | 22/50 | 19/49 | 30/50 | 18/50 | 28/50 | 29/50 | 27/50 | 37/49 | 29/49 | 29/51 | 36/50 | 28/50 | 33/50 | 10/50 | 8/50 | 7/49 | 22/50 | 13/50 | 13/50 | 19/50 | 18/50 | 21/49 | 10/50 | 23/50 | 14/50 | 19/50 |
| Headache (HEADACHE)Nervous system disorders | 22/51 | 17/50 | 13/49 | 25/50 | 12/50 | 20/50 | 22/50 | 21/50 | 25/49 | 21/49 | 26/51 | 28/50 | 20/50 | 25/50 | 7/50 | 11/50 | 11/49 | 12/50 | 14/50 | 12/50 | 17/50 | 10/50 | 12/49 | 11/50 | 12/50 | 14/50 | 18/50 |
| Chills (CHILLS)General disorders | 7/51 | 7/50 | 7/49 | 14/50 | 9/50 | 19/50 | 23/50 | 16/50 | 19/49 | 23/49 | 17/51 | 24/50 | 19/50 | 24/50 | 5/50 | 4/50 | 2/49 | 9/50 | 4/50 | 10/50 | 12/50 | 8/50 | 9/49 | 6/50 | 11/50 | 10/50 | 12/50 |
| Myalgia (MUSCLEPAIN)Musculoskeletal and connective tissue disorders | 10/51 | 9/50 | 6/49 | 18/50 | 7/50 | 15/50 | 18/50 | 10/50 | 21/49 | 13/49 | 19/51 | 18/50 | 16/50 | 19/50 | 6/50 | 7/50 | 7/49 | 6/50 | 6/50 | 9/50 | 14/50 | 6/50 | 10/49 | 11/50 | 14/50 | 12/50 | 14/50 |
| Arthralgia (JOINT PAIN)Musculoskeletal and connective tissue disorders | 4/51 | 4/50 | 7/49 | 13/50 | 5/50 | 10/50 | 13/50 | 4/50 | 10/49 | 9/49 | 14/51 | 12/50 | 9/50 | 13/50 | 5/50 | 7/50 | 5/49 | 5/50 | 4/50 | 6/50 | 9/50 | 3/50 | 4/49 | 6/50 | 7/50 | 6/50 | 9/50 |
| Injection site swelling (SWELLING)General disorders | 3/51 | 2/50 | 1/49 | 2/50 | 1/50 | 3/50 | 6/50 | 5/50 | 6/49 | 11/49 | 4/51 | 5/50 | 4/50 | 7/50 | 3/50 | 1/50 | 3/49 | 2/50 | 4/50 | 4/50 | 1/50 | 6/50 | 6/49 | 4/50 | 5/50 | 9/50 | 6/50 |
| Pyrexia (FEVER)General disorders | 1/51 | 1/50 | 1/49 | 1/50 | 1/50 | 5/50 | 3/50 | 4/50 | 9/49 | 3/49 | 6/51 | 5/50 | 9/50 | 8/50 | 2/50 | 1/50 | 1/49 | 3/50 | 0/50 | 2/50 | 3/50 | 1/50 | 1/49 | 0/50 | 5/50 | 2/50 | 4/50 |
| Diarrhoea (DIARRHEA)Gastrointestinal disorders | 6/51 | 7/50 | 3/49 | 3/50 | 5/50 | 3/50 | 8/50 | 8/50 | 7/49 | 6/49 | 4/51 | 6/50 | 5/50 | 4/50 | 5/50 | 2/50 | 2/49 | 2/50 | 5/50 | 3/50 | 0/50 | 4/50 | 7/49 | 1/50 | 2/50 | 6/50 | 4/50 |
| Injection site erythema (REDNESS)General disorders | 1/51 | 5/50 | 0/49 | 2/50 | 2/50 | 3/50 | 3/50 | 5/50 | 2/49 | 6/49 | 4/51 | 7/50 | 4/50 | 7/50 | 1/50 | 1/50 | 1/49 | 4/50 | 3/50 | 3/50 | 0/50 | 1/50 | 2/49 | 4/50 | 5/50 | 7/50 | 4/50 |
Baseline analysis population was evaluated on safety population which included all participants who received any study intervention.
| Age, Customized(Participants) | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1+ Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 18-64 years | 51 | 50 | 49 | 50 | 50 | 50 | 50 | 50 | 49 | 49 | 51 | 50 | 50 | 50 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 699 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 50 | 50 | 49 | 50 | 50 | 50 | 50 | 50 | 49 | 50 | 50 | 50 | 50 | 648 |
| Sex: Female, Male(Participants) | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1+ Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 31 | 25 | 25 | 27 | 29 | 29 | 27 | 29 | 29 | 23 | 34 | 25 | 28 | 31 | 20 | 31 | 31 | 28 | 28 | 21 | 31 | 31 | 23 | 16 | 24 | 32 | 23 | 731 |
| Male | 20 | 25 | 24 | 23 | 21 | 21 | 23 | 21 | 20 | 26 | 17 | 25 | 22 | 19 | 30 | 19 | 18 | 22 | 22 | 29 | 19 | 19 | 26 | 34 | 26 | 18 | 27 | 616 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1+ Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 12 | 16 | 14 | 10 | 17 | 12 | 18 | 18 | 14 | 13 | 16 | 11 | 20 | 17 | 20 | 20 | 19 | 17 | 16 | 18 | 19 | 18 | 20 | 22 | 26 | 24 | 24 | 471 |
| Not Hispanic or Latino | 38 | 34 | 35 | 38 | 33 | 37 | 31 | 30 | 35 | 36 | 35 | 39 | 29 | 33 | 30 | 30 | 30 | 32 | 34 | 32 | 31 | 31 | 29 | 28 | 24 | 25 | 25 | 864 |
| Unknown or Not Reported | 1 | 0 | 0 | 2 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 12 |
| Race (NIH/OMB)(Participants) | Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm E: Licensed Influenza Vaccine 1+ Licensed COVID-19 Vaccine | Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo | Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo | Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine | Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo | Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo | Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo | Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 |
| Asian | 5 | 4 | 5 | 8 | 1 | 4 | 4 | 4 | 1 | 2 | 6 | 4 | 3 | 3 | 0 | 2 | 1 | 0 | 2 | 0 | 2 | 3 | 2 | 3 | 1 | 1 | 1 | 72 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 3 |
| Black or African American | 12 | 15 | 12 | 11 | 19 | 15 | 12 | 9 | 9 | 13 | 17 | 14 | 14 | 9 | 11 | 13 | 11 | 16 | 6 | 14 | 9 | 10 | 9 | 11 | 7 | 13 | 10 | 321 |
| White | 31 | 30 | 32 | 30 | 29 | 29 | 33 | 35 | 37 | 33 | 27 | 28 | 32 | 38 | 38 | 34 | 37 | 34 | 40 | 35 | 39 | 35 | 37 | 36 | 42 | 34 | 39 | 924 |
| More than one race | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 18 |
| Unknown or Not Reported | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 6 |
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