A Study to Evaluate the Safety, Tolerability, and Immunog... | NCT06178991 | Trialant
NCT06178991
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Dec 4, 2025Actual
Enrollment
8,795Actual
Phase
Phase 3
Conditions
Influenza
COVID-19
Interventions
Influenza and COVID-19 Combination A
Licensed influenza vaccine
COVID-19 Vaccine
Influenza and COVID-19 Combination B
Placebo
Investigational influenza vaccine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT06178991
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C5261002
Secondary IDs
ID
Type
Description
Link
NCT06178991
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Official Title
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 20, 2023Actual
Primary Completion Date
Nov 26, 2024Actual
Completion Date
Nov 26, 2024Actual
First Submitted Date
Dec 20, 2023
First Submission Date that Met QC Criteria
Dec 20, 2023
First Posted Date
Dec 21, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Nov 21, 2025
Results First Submitted that Met QC Criteria
Nov 21, 2025
Results First Posted Date
Dec 4, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 21, 2025
Last Update Posted Date
Dec 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BioNTech SEINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
COVID-19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
8,795Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
Experimental
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Biological: Influenza and COVID-19 Combination A
Biological: Placebo
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Active Comparator
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Biological: Licensed influenza vaccine
Biological: COVID-19 Vaccine
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
Experimental
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Biological: Influenza and COVID-19 Combination B
Biological: Placebo
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Active Comparator
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Biological: Licensed influenza vaccine
Biological: COVID-19 Vaccine
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Influenza and COVID-19 Combination A
Biological
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day1]
Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
64 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
North Alabama Research Center
Athens
Alabama
35611
United States
Accel Research Sites - Birmingham Clinical Research Unit
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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 coronavirus disease 2019 (COVID-19) vaccine (combination A) and placebo, intramuscularly on Day 1.
FG001
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 11, 2024
Nov 19, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
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.
Who Masked
ParticipantInvestigator
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Biological: Influenza and COVID-19 Combination B
Cohort 3 Arm F: COVID-19 vaccine
Active Comparator
Cohort 3 Arm F: COVID-19 vaccine
Biological: COVID-19 Vaccine
Cohort 3 Arm G: Licensed influenza vaccine
Active Comparator
Cohort 3 Arm G: Licensed influenza vaccine
Biological: Licensed influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccine
Active Comparator
Cohort 3 Arm H: Investigational influenza vaccine
Biological: Investigational influenza vaccine
Licensed influenza vaccine
Biological
Licensed influenza vaccine
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 3 Arm G: Licensed influenza vaccine
COVID-19 Vaccine
Biological
Pfizer-BioNTech COVID-19 vaccine
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 3 Arm F: COVID-19 vaccine
Influenza and COVID-19 Combination B
Biological
Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Placebo
Biological
Saline Solution
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
Investigational influenza vaccine
Biological
Investigational influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccine
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.
From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.
From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.
From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority
GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 *LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
At 4 Weeks after Vaccination
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
Seroconversion was defined as having an HAI titer <1:10 prior to vaccination and greater than or equal to (>=) 1:40 at the postvaccination time point of interest, or an HAI titer of >=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
At 4 Weeks after Vaccination
Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.
At 4 Weeks after Vaccination
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority
Seroresponse was defined as achieving a postvaccination >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >=4*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section.
At 4 Weeks after Vaccination
At 4 Weeks after Vaccination
Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.
At 4 Weeks after Vaccination
Birmingham
Alabama
35216
United States
AMR Clinical
Mobile
Alabama
36608
United States
HOPE Research Institute
Phoenix
Arizona
85032
United States
Foothills Research Center/ CCT Research
Phoenix
Arizona
85044
United States
Scottsdale Clinical Trials
Scottsdale
Arizona
85260
United States
Alliance for Multispecialty Research, LLC
Tempe
Arizona
85281
United States
Baptist Health Center For Clinical Research
Little Rock
Arkansas
72205
United States
Hope Clinical Research, Inc.
Canoga Park
California
91303
United States
Ascada Health PC dba Ascada Research
Fullerton
California
92835
United States
Orange County Research Center
Lake Forest
California
92630
United States
Ark Clinical Research
Long Beach
California
90815
United States
Collaborative Neuroscience Research, LLC
Los Alamitos
California
90720
United States
Artemis Institute for Clinical Research
San Diego
California
92103
United States
Acclaim Clinical Research
San Diego
California
92120
United States
Bayview Research Group, LLC
Valley Village
California
91607
United States
Synexus Clinical Research US, Inc.
Vista
California
92083
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Tampa Bay Medical Research
Clearwater
Florida
33761
United States
Universal Axon Clinical Research, LLC
Doral
Florida
33166
United States
Proactive Clinical Research,LLC
Fort Lauderdale
Florida
33308
United States
Finlay Medical Research
Greenacres City
Florida
33467
United States
Indago Research & Health Center, Inc
Hialeah
Florida
33012
United States
Best Quality Research,Inc.
Hialeah
Florida
33016
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville
Florida
32256
United States
Miami Clinical Research
Miami
Florida
33155
United States
Gerardo Polanco, MD
Miami
Florida
33156
United States
Research Institute of South Florida
Miami
Florida
33173
United States
Entrust Clinical Research
Miami
Florida
33176
United States
Miami Dade Medical Research Institute, LLC
Miami
Florida
33176
United States
Clinical Site Partners LLC, dba Flourish Research
Miami
Florida
33186
United States
Palm Springs Community Health Center
Miami Lakes
Florida
33014
United States
Angels Clinical Research Institute
Miami Lakes
Florida
33016
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Innovation Medical Research Center
Palmetto Bay
Florida
33157
United States
DBC Research USA
Pembroke Pines
Florida
33029
United States
Angels Clinical Research Institute
Tampa
Florida
33614
United States
Centricity Research Columbus Georgia Multispecialty
Columbus
Georgia
31904
United States
AGILE Clinical Research Trials, LLC
Sandy Springs
Georgia
30328
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Clinical Research Prime
Idaho Falls
Idaho
83404
United States
Velocity Clinical Research, Boise
Meridian
Idaho
83642
United States
Solaris Clinical Research
Meridian
Idaho
83646
United States
Synexus Clinical Research US, Inc.
Chicago
Illinois
60602
United States
Great Lakes Clinical Trials - Ravenswood
Chicago
Illinois
60640
United States
Koch Family Medicine
Morton
Illinois
61550
United States
Velocity Clinical Research, Sioux City
Sioux City
Iowa
51106
United States
AMR Clinical
Wichita
Kansas
67207
United States
Pharmaron
Baltimore
Maryland
21201
United States
Jadestone Clinical Research
Silver Spring
Maryland
20904
United States
Headlands Research - Detroit
Southfield
Michigan
48034
United States
Revival Research Institute, LLC
Sterling Heights
Michigan
48312
United States
Clinical Research Professionals
Chesterfield
Missouri
63005
United States
Alliance for Multispecialty Research, LLC
Kansas City
Missouri
64114
United States
Saint Louis University Center for Vaccine Development
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio
Texas
78229
United States
IMA Clinical Research San Antonio
San Antonio
Texas
78229
United States
DM Clinical Research, Martin Diagnostic Clinic
Tomball
Texas
77375
United States
Northwest Houston Heart Center
Tomball
Texas
77375
United States
AMR Clinical
Layton
Utah
84041
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
Velocity Clinical Research, Salt Lake City
West Jordan
Utah
84088
United States
Health Research of Hampton Roads, Inc.
Newport News
Virginia
23606
United States
AMR Clinical
Norfolk
Virginia
23502
United States
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
FG002
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.
FG003
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.
FG004
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.
FG005
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
FG006
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
FG007
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
FG000313 subjects
FG001160 subjects
FG0023142 subjects
FG0031572 subjects
FG0041197 subjects
FG0051195 subjects
FG006607 subjects
FG007609 subjects
Vaccinated
FG000309 subjects
FG001159 subjects
FG0023127 subjects
FG0031563 subjects
FG0041189 subjects
FG0051191 subjects
FG006605 subjects
FG007607 subjects
COMPLETED
FG000304 subjects
FG001148 subjects
FG0022938 subjects
FG0031468 subjects
FG0041110 subjects
FG0051125 subjects
FG006571 subjects
FG007583 subjects
NOT COMPLETED
FG0009 subjects
FG00112 subjects
FG002204 subjects
FG003104 subjects
FG00487 subjects
FG00570 subjects
FG00636 subjects
FG00726 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0016 subjects
FG00244 subjects
FG00323 subjects
FG0047 subjects
FG0057 subjects
FG0067 subjects
FG0075 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG002133 subjects
FG00365 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Randomized but not Vaccinated
FG0004 subjects
FG0011 subjects
FG00215 subjects
FG0039 subjects
FG004
Other: Unspecified
FG0000 subjects
FG0011 subjects
FG0027 subjects
FG0036 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Baseline analysis population was evaluated on safety population which included all participants who received at least 1 dose of the study intervention. Participants were grouped according to the vaccine as administered in the analysis based on the safety population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
BG006
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
BG007
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000309
BG001159
BG0023127
BG0031563
BG0041189
BG0051191
BG006605
BG007607
BG0088750
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00044.2± 12.13
BG00144.7± 13.89
BG00244.0± 12.91
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000180
BG00195
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000105
BG00151
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
OG000308
OG001159
Title
Denominators
Categories
Title
Measurements
OG00074.7(69.4 to 79.4)
OG00159.1(51.1 to 66.8)
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Vaccination [Vaccination on Day1]
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
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.
OG001
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
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.
OG001
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination on Day 1 through 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination on Day 1 through 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination on Day 1 through 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 3, Arm F: COVID-19 Vaccine
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination on Day 1 through 6 Months after Vaccination
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination on Day 1 through 6 Months after Vaccination
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From Vaccination on Day 1 through 6 Months after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
OG002
Cohort 3, Arm G: Licensed Influenza Vaccine
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.
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".
Posted
Geometric Mean
95% Confidence Interval
Titer
At 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
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.
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".
Posted
Number
95% Confidence Interval
Percentage of participants
At 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
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.
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.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
At 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration
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.
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.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
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.
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.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 4 Weeks after Vaccination
ID
Title
Description
OG000
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.
OG001
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
Time Frame
Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: all-cause mortality and SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 4 weeks after Vaccination
Description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all participants who received at least 1 dose of the study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
1
309
2
309
245
309
EG001
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.
0
159
4
159
113
159
EG002
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.
2
3,127
23
3,127
2,521
3,127
EG003
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
1,563
22
1,563
1,152
1,563
EG004
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
1,189
10
1,189
941
1,189
EG005
Cohort 3, Arm F: COVID-19 Vaccine
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
0
1,191
15
1,191
843
1,191
EG006
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
1
605
5
605
330
605
EG007
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
1
607
7
607
456
607
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG0031 affected1,563 at risk
EG004
Acute cardiac event
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Chest pain
General disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Duodenal ulcer perforation
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Umbilical hernia, obstructive
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Hepatitis alcoholic
Hepatobiliary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Beta haemolytic streptococcal infection
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Device related bacteraemia
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Herpes zoster meningitis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Incision site cellulitis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Kidney infection
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0001 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Renal abscess
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Sepsis
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Septic shock
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Wound infection
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Traumatic liver injury
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Metastatic renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Spinal cord neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Brain stem stroke
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Seizure
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0001 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Seizure like phenomena
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Syncope
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Extremity necrosis
Vascular disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0021 affected3,127 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0011 affected159 at risk
EG0020 affected3,127 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected309 at risk
EG0010 affected159 at risk
EG0020 affected3,127 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0001 affected309 at risk
EG0012 affected159 at risk
EG00215 affected3,127 at risk
EG00310 affected1,563 at risk
EG0042 affected1,189 at risk
EG0052 affected1,191 at risk
EG0063 affected605 at risk
EG0070 affected607 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0004 affected309 at risk
EG0013 affected159 at risk
EG00215 affected3,127 at risk
EG003
Chills (CHILLS)
General disorders
MedDRA v27.1
Systematic Assessment
EG000117 affected309 at risk
EG00126 affected159 at risk
EG0021,163 affected3,127 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v27.1
Systematic Assessment
EG000180 affected309 at risk
EG00166 affected159 at risk
EG0021,780 affected3,127 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA v27.1
Systematic Assessment
EG00044 affected309 at risk
EG00111 affected159 at risk
EG002293 affected3,127 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA v27.1
Systematic Assessment
EG000227 affected309 at risk
EG00193 affected159 at risk
EG0022,259 affected3,127 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA v27.1
Systematic Assessment
EG00040 affected309 at risk
EG00112 affected159 at risk
EG002376 affected3,127 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v27.1
Systematic Assessment
EG00043 affected309 at risk
EG0014 affected159 at risk
EG002331 affected3,127 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG00045 affected309 at risk
EG00122 affected159 at risk
EG002446 affected3,127 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG00012 affected309 at risk
EG0013 affected159 at risk
EG002123 affected3,127 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG00077 affected309 at risk
EG00118 affected159 at risk
EG002640 affected3,127 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG000114 affected309 at risk
EG00123 affected159 at risk
EG0021,081 affected3,127 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG000147 affected309 at risk
EG00147 affected159 at risk
EG0021,403 affected3,127 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Sponsor (or its agents) has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
OG003
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
Units
Counts
Participants
OG0001186
OG0011188
OG002604
OG003606
Title
Denominators
Categories
Title
Measurements
OG00073.4(70.8 to 75.9)
OG00162.5(59.6 to 65.2)
OG00234.8(31.0 to 38.7)
OG00366.3(62.4 to 70.1)
Units
Counts
Participants
OG000308
OG001159
Title
Denominators
Categories
Title
Measurements
OG00071.8(66.4 to 76.7)
OG00154.1(46.0 to 62.0)
Units
Counts
Participants
OG0003111
OG0011560
Title
Denominators
Categories
Title
Measurements
OG00070.8(69.2 to 72.4)
OG00159.9(57.4 to 62.3)
OG002
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
OG003
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
Units
Counts
Participants
OG0001186
OG0011188
OG002604
OG003606
Title
Denominators
Categories
Title
Measurements
OG00066.7(63.9 to 69.4)
OG00152.1(49.2 to 55.0)
OG00243.9(39.9 to 47.9)
OG00361.1(57.0 to 65.0)
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
Units
Counts
Participants
OG000309
OG001159
Title
Denominators
Categories
Title
Measurements
OG0005.8(3.5 to 9.1)
OG00110.1(5.9 to 15.8)
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
Units
Counts
Participants
OG0003127
OG0011563
Title
Denominators
Categories
Title
Measurements
OG0006.4(5.6 to 7.3)
OG0016.1(4.9 to 7.4)
Participants 18 to 64 years of age were administered with COVID-19 vaccine, intramuscularly on Day 1.
OG002
Cohort 3, Arm G: Licensed Influenza Vaccine
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
OG003
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
Units
Counts
Participants
OG0001189
OG0011191
OG002605
OG003607
Title
Denominators
Categories
Title
Measurements
OG0003.8(2.8 to 5.0)
OG0014.8(3.6 to 6.2)
OG0024.1(2.7 to 6.0)
OG0034.1(2.7 to 6.0)
Units
Counts
Participants
OG000309
OG001159
Title
Denominators
Categories
Title
Measurements
OG0000.6(0.1 to 2.3)
OG0012.5(0.7 to 6.3)
Units
Counts
Participants
OG0003127
OG0011563
Title
Denominators
Categories
Title
Measurements
OG0000.7(0.5 to 1.1)
OG0011.4(0.9 to 2.1)
Participants 18 to 64 years of age were administered with licensed influenza vaccine, intramuscularly on Day 1.
OG003
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
Units
Counts
Participants
OG0001189
OG0011191
OG002605
OG003607
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.4 to 1.5)
OG0011.3(0.7 to 2.1)
OG0020.8(0.3 to 1.9)
OG0031.2(0.5 to 2.4)
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
Units
Counts
Participants
OG0001923
OG001967
Title
Denominators
Categories
H1N1
ParticipantsOG0001916
ParticipantsOG001964
Title
Measurements
OG000188.3(178.2 to 198.9)
OG001136.3(125.9 to 147.5)
H3N2
ParticipantsOG0001909
ParticipantsOG001954
Title
Measurements
OG000165.9(158.0 to 174.1)
OG001
Victoria
ParticipantsOG0001918
ParticipantsOG001965
Title
Measurements
OG00037.4(35.5 to 39.5)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
H1N1
GMR
1.38
2-Sided
95
1.25
1.52
GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for non-inferiority (NI) was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG001
H3N2
GMR
1.71
2-Sided
95
1.58
1.86
GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG001
Victoria
GMR
0.66
2-Sided
95
0.61
0.73
GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
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.
Units
Counts
Participants
OG0001923
OG001967
Title
Denominators
Categories
H1N1
ParticipantsOG0001913
ParticipantsOG001958
Title
Measurements
OG00072.8(70.7 to 74.8)
OG00154.9(51.7 to 58.1)
H3N2
ParticipantsOG0001887
ParticipantsOG001943
Title
Measurements
OG00065.7(63.5 to 67.8)
OG001
Victoria
ParticipantsOG0001915
ParticipantsOG001962
Title
Measurements
OG00031.7(29.6 to 33.8)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
H1N1
Difference in percentage of participants
17.9
2-Sided
95
14.1
21.6
Difference in percentage of participants achieving seroconversion (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroconversion was greater than -10%.
OG000
OG001
H3N2
Difference in percentage of participants
25.6
2-Sided
95
21.7
29.3
Difference in percentage of participants achieving seroconversion (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroconversion was greater than -10%.
OG000
OG001
Victoria
Difference in percentage of participants
-13.7
2-Sided
95
-17.5
-10.0
Difference in percentage of participants achieving seroconversion (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroconversion was greater than -10%.
Units
Counts
Participants
OG0002941
OG0011480
Title
Denominators
Categories
Title
Measurements
OG0003535.1(3370.0 to 3708.4)
OG0013476.6(3256.7 to 3711.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
1.02
2-Sided
95
0.94
1.10
GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
Participants 18 to 64 years of age were administered concomitantly with COVID-19 vaccine and licensed influenza vaccine administered, intramuscularly on Day 1.
Units
Counts
Participants
OG0002932
OG0011473
Title
Denominators
Categories
Title
Measurements
OG00075.5(73.9 to 77.1)
OG00173.7(71.4 to 76.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in percentage of participants
1.8
2-Sided
95
-0.9
4.6
Difference in percentage of participants achieving seroresponse (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroresponse was greater than -10%.
OG002
Cohort 3, Arm H: Investigational Influenza Vaccine
Participants 18 to 64 years of age were administered with investigational influenza vaccine, intramuscularly on Day 1.
Units
Counts
Participants
OG0001132
OG001579
OG002580
Title
Denominators
Categories
H1N1
ParticipantsOG0001132
ParticipantsOG001577
ParticipantsOG002580
Title
Measurements
OG000165.6(153.5 to 178.7)
OG001142.5(126.9 to 160.0)
OG002170.2(153.2 to 189.2)
H3N2
ParticipantsOG0001124
ParticipantsOG001572
ParticipantsOG002580
Title
Measurements
OG000
Victoria
ParticipantsOG0001132
ParticipantsOG001579
ParticipantsOG002580
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
H1N1
GMR
1.16
2-Sided
95
1.01
1.34
GMRs (ratio of Arm E to Arm G titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG002
H1N1
GMR
0.97
2-Sided
95
0.85
1.11
GMRs (ratio of Arm E to Arm H titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG001
H3N2
GMR
1.75
2-Sided
95
1.56
1.97
GMRs (ratio of Arm E to Arm G titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG002
H3N2
GMR
0.92
2-Sided
95
0.82
1.03
GMRs (ratio of Arm E to Arm H titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG001
Victoria
GMR
0.58
2-Sided
95
0.52
0.66
GMRs (ratio of Arm E to Arm G titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
OG000
OG002
Victoria
GMR
1.25
2-Sided
95
1.11
1.40
GMRs (ratio of Arm E to Arm H titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.
Units
Counts
Participants
OG0001120
OG0011135
Title
Denominators
Categories
Title
Measurements
OG0003841.0(3577.3 to 4124.1)
OG0014208.9(3901.8 to 4540.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
0.91
2-Sided
95
0.82
1.01
GMRs (ratio of Arm E to Arm F titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).
Non-Inferiority
The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.