COVID-19, Influenza
Conditions
Brief summary
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: * Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm. * Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm. Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following: * Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm. * Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm. Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following: * Group E: Influenza and COVID-19 combination B vaccine. * Group F: COVID-19 vaccine. * Group G: Licenced influenza vaccine. * Group H: Investigational influenza vaccine. 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.
Interventions
BIOLOGICALInfluenza and COVID-19 Combination A
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
BIOLOGICALLicensed influenza vaccine
Licensed influenza vaccine
BIOLOGICALCOVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine
BIOLOGICALInfluenza and COVID-19 Combination B
Combined influenza and Pfizer-BioNTech COVID-19 vaccine
BIOLOGICALPlacebo
Saline Solution
BIOLOGICALInvestigational influenza vaccine
Investigational influenza vaccine
Sponsors
Pfizer
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion criteria
* Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. * Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration. Please refer to the study contact for further eligibility details
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority | At 4 Weeks after Vaccination | Seroresponse was defined as achieving a postvaccination \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>=4\*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section. |
| Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | At 4 Weeks after Vaccination | Seroconversion was defined as having an HAI titer \<1:10 prior to vaccination and greater than or equal to (\>=) 1:40 at the postvaccination time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria. |
| Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority | At 4 Weeks after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. |
| Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure. |
| Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | From Day 1 through Day 7 after Vaccination [Vaccination on Day1] | Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure. |
| Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure. |
| Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure. |
| Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure. |
| Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure. |
| Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | From Vaccination on Day 1 through 4 Weeks after Vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure. |
| Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | From Vaccination on Day 1 through 4 Weeks after Vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure. |
| Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | From Vaccination on Day 1 through 4 Weeks after Vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure. |
| Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | From Vaccination on Day 1 through 6 Months after Vaccination | SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. |
| Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | From Vaccination on Day 1 through 6 Months after Vaccination | SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. |
| Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | From Vaccination on Day 1 through 6 Months after Vaccination | SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. |
| Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority | At 4 Weeks after Vaccination | GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority | At 4 Weeks after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. |
| Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | At 4 Weeks after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for reported for following strains: H1N1, H3N2 and Victoria. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination A) and placebo, intramuscularly on Day 1. | 309 |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1. | 159 |
| Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo Participants 18 to 64 years of age were administered with Influenza and COVID-19 vaccine (combination B) and placebo, intramuscularly on Day 1. | 3,127 |
| Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1. | 1,563 |
| Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B) Participants 18 to 64 years of age were administered with Influenza vaccine and COVID-19 vaccine (combination B), intramuscularly on Day 1. | 1,189 |
| Cohort 3, Arm F: COVID-19 Vaccine Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1. | 1,191 |
| Cohort 3, Arm G: Licensed Influenza Vaccine Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1. | 605 |
| Cohort 3, Arm H: Investigational Influenza Vaccine Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1. | 607 |
| Total | 8,750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 2 | 1 | 1 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 | 133 | 65 | 68 | 57 | 25 | 18 |
| Overall Study | Other: Unspecified | 0 | 1 | 7 | 6 | 1 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 2 | 0 | 2 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Randomized but not Vaccinated | 4 | 1 | 15 | 9 | 8 | 4 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 6 | 44 | 23 | 7 | 7 | 7 | 5 |
Baseline characteristics
| Characteristic | Cohort 3, Arm H: Investigational Influenza Vaccine | Total | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 45.1 Years STANDARD_DEVIATION 12.82 | 44.4 Years STANDARD_DEVIATION 12.73 | 44.2 Years STANDARD_DEVIATION 12.13 | 44.7 Years STANDARD_DEVIATION 13.89 | 44.0 Years STANDARD_DEVIATION 12.91 | 44.2 Years STANDARD_DEVIATION 12.53 | 44.3 Years STANDARD_DEVIATION 12.72 | 45.3 Years STANDARD_DEVIATION 12.45 | 44.5 Years STANDARD_DEVIATION 12.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 225 Participants | 2954 Participants | 105 Participants | 51 Participants | 966 Participants | 491 Participants | 457 Participants | 435 Participants | 224 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 371 Participants | 5710 Participants | 201 Participants | 108 Participants | 2145 Participants | 1055 Participants | 719 Participants | 739 Participants | 372 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 86 Participants | 3 Participants | 0 Participants | 16 Participants | 17 Participants | 13 Participants | 17 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 63 Participants | 0 Participants | 1 Participants | 22 Participants | 17 Participants | 13 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 286 Participants | 4 Participants | 6 Participants | 111 Participants | 58 Participants | 35 Participants | 34 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 157 Participants | 2187 Participants | 74 Participants | 37 Participants | 812 Participants | 392 Participants | 277 Participants | 295 Participants | 143 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 90 Participants | 1 Participants | 2 Participants | 32 Participants | 24 Participants | 15 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 31 Participants | 1 Participants | 0 Participants | 12 Participants | 2 Participants | 9 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 82 Participants | 2 Participants | 2 Participants | 32 Participants | 19 Participants | 10 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) White | 419 Participants | 6011 Participants | 227 Participants | 111 Participants | 2106 Participants | 1051 Participants | 830 Participants | 842 Participants | 425 Participants |
| Sex: Female, Male Female | 332 Participants | 4868 Participants | 180 Participants | 95 Participants | 1740 Participants | 848 Participants | 654 Participants | 683 Participants | 336 Participants |
| Sex: Female, Male Male | 275 Participants | 3882 Participants | 129 Participants | 64 Participants | 1387 Participants | 715 Participants | 535 Participants | 508 Participants | 269 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 309 | 0 / 159 | 2 / 3,127 | 1 / 1,563 | 1 / 1,189 | 0 / 1,191 | 1 / 605 | 1 / 607 |
| other Total, other adverse events | 245 / 309 | 113 / 159 | 2,521 / 3,127 | 1,152 / 1,563 | 941 / 1,189 | 843 / 1,191 | 330 / 605 | 456 / 607 |
| serious Total, serious adverse events | 2 / 309 | 4 / 159 | 23 / 3,127 | 22 / 1,563 | 10 / 1,189 | 15 / 1,191 | 5 / 605 | 7 / 607 |
Outcome results
Primary
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
Population: Safety analysis population 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 5.8 Percentage of participants |
| 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 | 10.1 Percentage of participants |
Primary
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
Population: Safety analysis population 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.6 Percentage of participants |
| 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 | 2.5 Percentage of participants |
Primary
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]
Population: Safety analysis population 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. Here Overall Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination. As planned this outcome measure evaluated local reactions in investigational vaccine extremity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 74.7 Percentage of participants |
| 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 | 59.1 Percentage of participants |
Primary
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]
Population: Safety analysis population 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. Here Overall Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 71.8 Percentage of participants |
| 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 | 54.1 Percentage of participants |
Primary
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
Population: Evaluable immunogenicity population (EIP): eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for HAI of Cohort 2 was utilized. Number Analyzed: participants evaluable for specific strains. All participants for Overall Number of Participants Analyzed added to the data but may not be present as Number Analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 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 | H1N1 | 188.3 Titer |
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 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 | H3N2 | 165.9 Titer |
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 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 | Victoria | 37.4 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 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 | H1N1 | 136.3 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 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 | H3N2 | 96.9 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | 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 | Victoria | 56.4 Titer |
Comparison: H1N195% CI: [1.25, 1.52]
Comparison: H3N295% CI: [1.58, 1.86]
Comparison: Victoria95% CI: [0.61, 0.73]
Primary
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
Population: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for SARS-CoV-2 neutralization of Cohort 2 was utilized. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 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 Titer |
| Cohort 1, Arm B: 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 | 3476.6 Titer |
95% CI: [0.94, 1.1]
Primary
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
Population: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for SARS-CoV-2 neutralization of Cohort 2 was utilized. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | 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 Percentage of participants |
| Cohort 1, Arm B: 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 | 73.7 Percentage of participants |
95% CI: [-0.9, 4.6]
Primary
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
Population: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for HAI of Cohort 2 was utilized. Number Analyzed: participants evaluable for specific strains. All participants for Overall Number of Participants Analyzed added to the data but may not be present as Number Analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | H1N1 | 72.8 Percentage of participants |
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | H3N2 | 65.7 Percentage of participants |
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | Victoria | 31.7 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | H1N1 | 54.9 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | H3N2 | 40.1 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority | Victoria | 45.4 Percentage of participants |
Comparison: H1N195% CI: [14.1, 21.6]
Comparison: H3N295% CI: [21.7, 29.3]
Comparison: Victoria95% CI: [-17.5, -10]
Primary
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
Population: Safety analysis population 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 6.4 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 6.1 Percentage of participants |
Primary
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
Population: Safety analysis population 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.7 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 1.4 Percentage of participants |
Primary
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]
Population: Safety analysis population 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. Here Overall Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination. As planned this outcome measure evaluated local reactions in investigational vaccine extremity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 73.4 Percentage of participants |
| Cohort 1, Arm B: 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 | 63.5 Percentage of participants |
Primary
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]
Population: Safety analysis population 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. Here Overall Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 70.8 Percentage of participants |
| Cohort 1, Arm B: 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 | 59.9 Percentage of participants |
Primary
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
Population: Safety analysis population 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 3.8 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 4.8 Percentage of participants |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 4.1 Percentage of participants |
| Cohort 3, Arm H: Investigational Influenza Vaccine | Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination | 4.1 Percentage of participants |
Primary
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
Population: Safety analysis population 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.8 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 1.3 Percentage of participants |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 0.8 Percentage of participants |
| Cohort 3, Arm H: Investigational Influenza Vaccine | Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | 1.2 Percentage of participants |
Primary
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]
Population: Safety analysis population 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. Here Overall Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination. As planned this outcome measure evaluated local reactions in investigational vaccine extremity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 73.4 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 62.5 Percentage of participants |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity | 34.8 Percentage of participants |
| 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 | 66.3 Percentage of participants |
Primary
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]
Population: Safety analysis population 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. Here Overall Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 66.7 Percentage of participants |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 52.1 Percentage of participants |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 43.9 Percentage of participants |
| Cohort 3, Arm H: Investigational Influenza Vaccine | Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | 61.1 Percentage of participants |
Secondary
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
Population: EIP: eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27-42 days postvaccination, and had no major protocol violations. EIP for SARS-CoV-2 neutralization of Cohort 3 was utilized. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure. Per plan only those arms where COVID-19 vaccine was administered were evaluated.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority | 3841.0 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority | 4208.9 Titer |
95% CI: [0.82, 1.01]
Secondary
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
Population: EIP:eligible participants, received study intervention per randomization, had minimum 1 valid and determinate immunogenicity result from blood sample collected within 27- 42 days postvaccination, and had no major protocol violations. EIP for HAI of Cohort 3 was utilized. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable at specific strains. Per plan only those arms where influenza vaccine was administered were evaluated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | Victoria | 39.2 Titer |
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | H1N1 | 165.6 Titer |
| Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | H3N2 | 175.7 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | Victoria | 67.4 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | H1N1 | 142.5 Titer |
| Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | H3N2 | 100.1 Titer |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | Victoria | 31.5 Titer |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | H1N1 | 170.2 Titer |
| Cohort 3, Arm G: Licensed Influenza Vaccine | Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority | H3N2 | 190.4 Titer |
Comparison: H1N195% CI: [1.01, 1.34]
Comparison: H1N195% CI: [0.85, 1.11]
Comparison: H3N295% CI: [1.56, 1.97]
Comparison: H3N295% CI: [0.82, 1.03]
Comparison: Victoria95% CI: [0.52, 0.66]
Comparison: Victoria95% CI: [1.11, 1.4]