A Study to Evaluate a Modified RNA Vaccine Against Influe... | NCT05540522 | Trialant
NCT05540522
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 8, 2025Actual
Enrollment
45,789Actual
Phase
Phase 3
Conditions
Influenza, Human
Interventions
Quadrivalent influenza modRNA vaccine
Quadrivalent influenza vaccine
Countries
United States
Argentina
Chile
New Zealand
Philippines
South Africa
Protocol Section
Identification Module
NCT ID
NCT05540522
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4781004
Secondary IDs
ID
Type
Description
Link
NCT05540522
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
Official Title
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA COMPARED TO LICENSED INACTIVATED INFLUENZA VACCINE IN HEALTHY ADULTS 18 YEARS OF AGE OR OLDER
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 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
Sep 12, 2022Actual
Primary Completion Date
Mar 12, 2024Actual
Completion Date
Mar 12, 2024Actual
First Submitted Date
Sep 8, 2022
First Submission Date that Met QC Criteria
Sep 12, 2022
First Posted Date
Sep 14, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Mar 11, 2025
Results First Submitted that Met QC Criteria
Apr 18, 2025
Results First Posted Date
May 8, 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
Apr 18, 2025
Last Update Posted Date
May 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
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
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.
Detailed Description
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 seasonally recommended strains (2 A strains and 2 B strains) compared to licensed quadrivalent influenza vaccine (QIV) in healthy adults 18 years of age and older.
Participants may be enrolled in either the reactogenicity subset, immunogenicity subset, or both/neither subset(s). Efficacy will be assessed in this study through surveillance for influenza-like illness.
Conditions Module
Conditions
Influenza, Human
Keywords
Grippe
Flu
Influenza
Vaccine
RNA vaccine
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
45,789Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Quadrivalent influenza modRNA vaccine, 18 through 64 years of age
Experimental
Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age
Biological: Quadrivalent influenza modRNA vaccine
Quadrivalent influenza vaccine, 18 through 64 years of age
Active Comparator
Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age
Biological: Quadrivalent influenza vaccine
Quadrivalent influenza modRNA vaccine, ≥65 years of age
Experimental
Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age
Biological: Quadrivalent influenza modRNA vaccine
Quadrivalent influenza vaccine, ≥65 years of age
Active Comparator
Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age
Quadrivalent influenza modRNA vaccine, 18 through 64 years of age
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants ≥18 years of age at Visit 1 (Day 1).
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
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.
Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria:
Medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Allergy to egg proteins (egg or egg products) or chicken proteins.
Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study.
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.
Any participant who has received or plans to receive a modRNA-platform SARS CoV-2 vaccine within 14 days before or after study vaccination at Visit 1.
Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Fitz-Patrick D, McVinnie DS, Jackson LA, Crowther G, Geevarughese A, Cannon KD, Garcia LM, Pineiro Puebla Y, Yi Z, Cunliffe L, Maniar A, Zareba AM, Ianos CA, Gomme E, Koury K, Suphaphiphat Allen P, Anderson AS, Gurtman A, Lindert K; Pfizer C4781004 Trial Investigators. Efficacy, Immunogenicity, and Safety of Modified mRNA Influenza Vaccine. N Engl J Med. 2025 Nov 20;393(20):2001-2011. doi: 10.1056/NEJMoa2416779.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Participants from northern hemisphere 2022-2023 and southern hemisphere 2023 were to be enrolled during respective influenza seasons and were stratified into 2 age groups: 18 to 64 years and more than or equal to (>=) 65 years.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of quadrivalent influenza modified ribonucleic acid (modRNA) vaccine (qIRV) dose level 1 (low) intramuscularly (IM) on Day 1.
FG001
Licensed QIV: 18-64 Years
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
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
Jun 27, 2023
Mar 11, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Brazil
Submission Tracking
Estimated Results First Submitted Date
Not provided
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
Quadruple
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Quadrivalent influenza vaccine, 18 through 64 years of age
Quadrivalent influenza vaccine, ≥65 years of age
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years
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. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 4 weeks after study vaccination
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years
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. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 4 weeks after study vaccination
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years
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. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 4 weeks after study vaccination
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years
An 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.
From Day 1 up to 6 months after vaccination
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years
An 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.
From Day 1 up to 6 months after vaccination
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years
An 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.
From Day 1 up to 6 months after vaccination
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
CCI was defined as influenza infection confirmed through culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of CCI With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
CCI was defined as influenza infection confirmed through culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified Centers for Disease Control and Prevention (CDC) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified CDC Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI defined modified CDC: occurrence (new onset or worsening of preexisting condition) of at least 1 of the following respiratory symptoms concurrently with an oral temperature >37.2 deg C (>99.0 deg F), sore throat or cough. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by World Health Organization (WHO) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature >=38.0 deg C (>= 100.4 deg F). Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by WHO Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature >=38.0 deg C (>= 100.4 deg F). Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: 18-64 Years
Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by Central RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: >=65 Years
Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Geometric mean titers (GMTs) and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. Geometric mean ratios (GMRs) were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
4 Weeks after vaccination
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
4 Weeks after vaccination
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
4 Weeks after vaccination
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
4 Weeks after vaccination
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years
GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
4 Weeks after vaccination
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years
GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
4 Weeks after vaccination
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
4 Weeks after vaccination
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
4 Weeks after vaccination
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
Baseline (Before Vaccination)
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline (Before Vaccination)
HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Before vaccination (Baseline) to 4 weeks after vaccination
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Before vaccination (Baseline) to 4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Baseline and 4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline and 4 weeks after vaccination
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
Baseline
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Before vaccination (Baseline) to 4 weeks after vaccination
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination.
Before vaccination (Baseline) to 4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline and 4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline and 4 weeks after vaccination
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
Baseline and 4 weeks after vaccination
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline and 4 weeks after vaccination
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years
Before vaccination (Baseline) to 4 weeks after vaccination
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Before vaccination (Baseline) to 4 weeks after vaccination
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
4 weeks after vaccination
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest.
4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
Baseline and 4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Baseline and 4 weeks after vaccination
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline and 4 weeks after vaccination
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline and 4 weeks after vaccination
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years
Before Vaccination (baseline) to 4 weeks after vaccination
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Before vaccination (baseline) to 4 weeks after vaccination
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
4 weeks after vaccination
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest.
4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
Baseline and 4 weeks after vaccination
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Baseline and 4 weeks after vaccination
Birmingham
Alabama
35205
United States
Accel Research Sites Network - Birmingham Clinical Research Unit
Birmingham
Alabama
35216
United States
Ross Bridge Medical Practice, LLC-CCT Research
Birmingham
Alabama
35226
United States
SEC Clinical Research
Dothan
Alabama
36305
United States
Lakeview Clinical Research
Guntersville
Alabama
35976
United States
Medical Affiliated Research Center
Huntsville
Alabama
35801
United States
Lenzmeier Family Medicine/CCT Research
Glendale
Arizona
85308
United States
Aventiv Research
Mesa
Arizona
85206
United States
Desert Clinical Research/ CCT Research
Mesa
Arizona
85213
United States
HOPE Research Institute
Phoenix
Arizona
85018
United States
The Pain Center of Arizona
Phoenix
Arizona
85018
United States
HOPE Research Institute - Phoenix
Phoenix
Arizona
85023
United States
HOPE Research Institute
Phoenix
Arizona
85023
United States
Foothills Research Center/ CCT Research
Phoenix
Arizona
85044
United States
Epic Medical Research - Surprise
Surprise
Arizona
85378
United States
Fiel Family and Sports Medicine, PC/CCT Research
Tempe
Arizona
85283
United States
HOPE Research Institute
Tempe
Arizona
85284
United States
Noble Clinical Research
Tucson
Arizona
85704
United States
Baptist Health Center For Clinical Research
Little Rock
Arkansas
72205
United States
Applied Research Center of Arkansas
Little Rock
Arkansas
72212
United States
Anaheim Clinical Trials
Anaheim
California
92801
United States
Velocity Clinical Research, San Bernardino
Banning
California
92220
United States
Benchmark Research
Colton
California
92324
United States
Ascada Health PC dba Ascada Research
Fullerton
California
92835
United States
Marvel Clinical Research
Huntington Beach
California
92647
United States
Velocity Clinical Research, Huntington Park
Huntington Park
California
90255
United States
Velocity Clinical Research, San Diego
La Mesa
California
91942
United States
Orange County Research Center
Lake Forest
California
92630
United States
Ark Clinical Research
Long Beach
California
90815
United States
Kaiser Permanente
Los Angeles
California
90027
United States
Velocity Clinical Research, Westlake
Los Angeles
California
90057
United States
Velocity Clinical Research, North Hollywood
North Hollywood
California
91606
United States
Center for Clinical Trials, LLC
Paramount
California
90723
United States
Empire Clinical Research
Pomona
California
91767
United States
Paradigm Clinical Research Centers, Inc
Redding
California
96001
United States
Peninsula Research Associates
Rolling Hills Estates
California
90274
United States
Benchmark Research
Sacramento
California
95864
United States
Artemis Institute for Clinical Research
San Diego
California
92103
United States
Wr-McCr, Llc
San Diego
California
92120
United States
California Research Foundation
San Diego
California
92123
United States
Encompass Clinical Research
Spring Valley
California
91978
United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake
California
91602
United States
Collaborative Neuroscience Research, LLC
Torrance
California
90504
United States
Ark Clinical Research - Tustin
Tustin
California
92780
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Lynn Institute of Denver
Aurora
Colorado
80012
United States
Tekton Research, LLC.
Fort Collins
Colorado
80525
United States
Tekton Research, LLC.
Longmont
Colorado
80501
United States
Paradigm Clinical Research Centers, Inc
Wheat Ridge
Colorado
80033
United States
New England Research Associates, LLC
Bridgeport
Connecticut
06606
United States
Clinical Research Consulting
Milford
Connecticut
06460
United States
New Haven Clinical Research Unit
New Haven
Connecticut
06511
United States
Yale Cardiology
New Haven
Connecticut
06519
United States
Yale University School of Medicine
New Haven
Connecticut
06519
United States
Stamford Therapeutics Consortium
Stamford
Connecticut
06905
United States
Washington Health Institute
Washington D.C.
District of Columbia
20017
United States
JEM Research Institute
Atlantis
Florida
33462
United States
Tampa Bay Medical Research
Clearwater
Florida
33761
United States
Alliance for Multispecialty Research, LLC
Coral Gables
Florida
33134
United States
Universal Axon Clinical Research, LLC
Doral
Florida
33166
United States
Fleming Island Center for Clinical Research
Fleming Island
Florida
32003
United States
Proactive Clinical Research,LLC
Fort Lauderdale
Florida
33308
United States
Alliance for Multispecialty Research, LLC
Fort Myers
Florida
33912
United States
Robert B. Pritt, DO
Fort Myers
Florida
33912
United States
Best Quality Research,Inc.
Hialeah
Florida
33016
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville
Florida
32256
United States
Health Awareness
Jupiter
Florida
33458
United States
Wr-Msra.Llc
Lake City
Florida
32055
United States
JEM Research Institute
Lake Worth
Florida
33462
United States
Accel Research Sites Network - Lakeland Clinical Research Unit
Lakeland
Florida
33803
United States
Accel Research Sites - St. Petersburg Clinical Research Unit
Largo
Florida
33777
United States
Accel Research Sites Network - Maitland Clinical Research Unit
Maitland
Florida
32751
United States
Care Research - West Flagler Street
Miami
Florida
33130
United States
Gerardo Polanco, MD
Miami
Florida
33156
United States
Entrust Clinical Research
Miami
Florida
33176
United States
Miami Dade Medical Research Institute, LLC
Miami
Florida
33176
United States
Palm Springs Community Health Center
Miami Lakes
Florida
33014
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Headlands Research Orlando
Orlando
Florida
32819
United States
Innovation Medical Research Center
Palmetto Bay
Florida
33157
United States
DBC Research USA
Pembroke Pines
Florida
33029
United States
United Medical Research
Port Orange
Florida
32127
United States
Genesis Clinical Research, LLC
Tampa
Florida
33603
United States
Angels Clinical Research Institute
Tampa
Florida
33614
United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park
Florida
32789
United States
Centricity Research Columbus Georgia Multispecialty
Columbus
Georgia
31904
United States
IACT Health
Rincon
Georgia
31326
United States
Centricity Research Rincon Pulmonology
Rincon
Georgia
31406
United States
AGILE Clinical Research Trials, LLC
Sandy Springs
Georgia
30328
United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs
Georgia
30328
United States
CenExel iResearch, LLC
Savannah
Georgia
31405
United States
Javara - Privia Medical Group Georgia - Savannah
Savannah
Georgia
31406
United States
Velocity Clinical Research, Savannah
Savannah
Georgia
31406
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City
Georgia
30291
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Clinical Research Prime
Idaho Falls
Idaho
83404
United States
Solaris Clinical Research
Meridian
Idaho
83646
United States
Koch Family Medicine
Morton
Illinois
61550
United States
Accellacare - DuPage
Oak Lawn
Illinois
60453
United States
MediSphere Medical Research Center - Evansville - West Franklin Street
Evansville
Indiana
47712
United States
MediSphere Medical Research Center - EAST
Evansville
Indiana
47714
United States
Velocity Clinical Research, Valparaiso
Valparaiso
Indiana
46383
United States
University of Iowa
Iowa City
Iowa
52242
United States
Velocity Clinical Research, Sioux City
Sioux City
Iowa
51106
United States
Alliance for Multispecialty Research, LLC
Newton
Kansas
67114
United States
Alliance for Multispecialty Research, LLC
Wichita
Kansas
67205
United States
Alliance for Multispecialty Research, LLC
Wichita
Kansas
67207
United States
Alliance for Multispecialty Research, LLC
Lexington
Kentucky
40509
United States
Versailles Family Medicine / CCT Research
Versailles
Kentucky
40383
United States
MedPharmics, LLC
Lafayette
Louisiana
70508
United States
DelRicht Research
New Orleans
Louisiana
70115
United States
Alliance for Multispecialty Research, LLC
New Orleans
Louisiana
70119
United States
Louisiana State University Health Sciences Shreveport
Shreveport
Louisiana
71101
United States
Pharmaron
Baltimore
Maryland
21201
United States
Advanced Primary and Geriatric Care - CCT Research
Rockville
Maryland
20850
United States
Jadestone Clinical Research
Silver Spring
Maryland
20904
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
Boston Medical Center
Boston
Massachusetts
02118
United States
ActivMed Practices and Research
Methuen
Massachusetts
01844
United States
University of Massachusetts Chan Medical School
Worcester
Massachusetts
01655
United States
Henry Ford Hospital
Detroit
Michigan
48202
United States
Ascension St. John Hospital
Grosse Pointe Woods
Michigan
48236
United States
Revival Research Institute, LLC
Sterling Heights
Michigan
48312
United States
Oakland Medical Research
Troy
Michigan
48085
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires
1426
Argentina
Enroll SpA
Santiago
Santiago Metropolitan
7500587
Chile
Centro Skin Med Limitada
Santiago
Santiago Metropolitan
7580206
Chile
CECIM
Santiago
Santiago Metropolitan
8330336
Chile
Pacific Clinical Research Network - Rotorua
Rotorua
Bay of Plenty
3010
New Zealand
P3 Research - Tauranga
Tauranga
Bay of Plenty
3110
New Zealand
Pacific Clinical Research Network - Forte
Christchurch
Canterbury
8013
New Zealand
P3 Research - Hawke's Bay
Hastings
Hawke's Bay Region
4122
New Zealand
Lakeland Clinical Trials Waikato
Hamilton
Waikato Region
3200
New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt
Wellington Region
5018
New Zealand
Southern Clinical Trials Totara
Auckland
0600
New Zealand
Optimal Clinical Trials North
Auckland
0632
New Zealand
Optimal Clinical Trials
Auckland
1010
New Zealand
Southern Clinical Trials Tasman
Nelson
7011
New Zealand
P3 Research - Wellington
Wellington
6021
New Zealand
West Visayas State University Medical Center
Iloilo City
Iloilo
5000
Philippines
Tropical Disease Foundation
Makati City
National Capital Region
1230
Philippines
Health Cube Medical Clinics
Mandaluyong
National Capital Region
1552
Philippines
Mary Johnston Hospital
Manila
National Capital Region
1012
Philippines
Lung Center of the Philippines
Quezon City
National Capital Region
1100
Philippines
Far Eastern University Nicanor Reyes Medical Foundation
Quezon City
National Capital Region
1118
Philippines
Adventist Hospital Palawan
Puerto Princesa City
Palawan
5300
Philippines
De La Salle Medical and Health Sciences Institute
Dasmariñas
4114
Philippines
De La Salle Health Sciences Institute
Dasmariñas
Philippines
Iloilo Doctors' Hospital
Iloilo City
5000
Philippines
St. Paul's Hospital of Iloilo, Inc.
Iloilo City
5000
Philippines
Philippine General Hospital
Manila
1000
Philippines
Synergy Biomed Research Institute
East London
Eastern Cape
5241
South Africa
Phoenix Pharma
Port Elizabeth
Eastern Cape
6001
South Africa
Iatros International
Bloemfontein
Free State
9301
South Africa
Josha Research
Bloemfontein
Free State
9301
South Africa
Worthwhile Clinical Trials
Benoni
Gauteng
1500
South Africa
REIMED Reiger Park
Boksburg
Gauteng
1459
South Africa
Soweto Clinical Trials Centre
Johannesburg
Gauteng
1818
South Africa
Clinresco Centres
Kempton Park
Gauteng
1619
South Africa
Ubuntu Clinical Research - Krugersdorp
Krugersdorp
Gauteng
1739
South Africa
Ubuntu Clinical Research - Lenasia
Lenasia
Gauteng
1827
South Africa
Zinakekele Medicall Centre
Moloto
Gauteng
1022
South Africa
Emmed Research
Pretoria
Gauteng
0002
South Africa
Setshaba Research Centre
Pretoria
Gauteng
0152
South Africa
Global Clinical Trials
Pretoria
Gauteng
0157
South Africa
Botho Ke Bontle Health Services
Pretoria
Gauteng
0184
South Africa
Jongaie Research
Pretoria West
Gauteng
0183
South Africa
Wits Clinical Research
Soweto
Gauteng
2013
South Africa
Synexus Watermeyer Clinical Research Centre
Val de Grace
Gauteng
0184
South Africa
FCRN Clinical Trial Centre
Vereeniging
Gauteng
1935
South Africa
Precise Clinical Solutions
Chatsworth
KwaZulu-Natal
4092
South Africa
Private Practice - Dr. Peter Sebastian
Chatsworth
KwaZulu-Natal
4092
South Africa
Synapta Clinical Research Centre
Durban
KwaZulu-Natal
4001
South Africa
MERCLINCO Middleburg
Middelburg
Mpumalanga
1050
South Africa
Aurum Institute - Rustenburg
Rustenburg
North West
0299
South Africa
TREAD Research (Pty)Ltd
Cape Town
Western Cape
7500
South Africa
TASK Applied Science
Cape Town
Western Cape
7530
South Africa
Tiervlei Trial Centre
Cape Town
Western Cape
7530
South Africa
TREAD Research
Cape Town
Western Cape
7530
South Africa
Umzimkhulu Research Centre
uMzimkhulu
3297
South Africa
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed quadrivalent influenza vaccine (QIV) IM per investigational product manual (IPM) on Day 1.
FG002
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
FG003
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
FG0009247 subjects
FG0019251 subjects
FG00213635 subjects
FG00313656 subjects
Safety Set
Includes all randomized participants who received any study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
FG0009191 subjects
FG0019197 subjects
FG00213557 subjects
FG00313611 subjects
COMPLETED
FG0008527 subjects
FG0018598 subjects
FG00213026 subjects
FG00313043 subjects
NOT COMPLETED
FG000720 subjects
FG001653 subjects
FG002609 subjects
FG003613 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0035 subjects
Lost to Follow-up
FG000487 subjects
FG001427 subjects
FG002146 subjects
FG003166 subjects
Physician Decision
FG00011 subjects
FG00119 subjects
FG0028 subjects
FG00313 subjects
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0003 subjects
FG0011 subjects
FG0029 subjects
FG0037 subjects
Withdrawal by Subject
FG000168 subjects
FG001134 subjects
FG002331 subjects
FG003322 subjects
Death
FG0007 subjects
FG0019 subjects
FG00249 subjects
FG00346 subjects
Not vaccinated
FG00034 subjects
FG00153 subjects
FG00257 subjects
FG00350 subjects
No longer meets eligibility criteria
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
Other (Unspecified)
FG0008 subjects
FG00110 subjects
FG0024 subjects
FG0032 subjects
Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
BG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
BG002
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
BG003
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009191
BG0019197
BG00213557
BG00313611
BG00445556
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
BG00042.9± 13.05
BG00143.1± 13.07
BG00270.9± 4.91
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005395
BG0015293
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001961
BG0011955
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00073
BG00169
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
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population included all participants who were eligible, received the study intervention to which they were randomized, and had no important protocol deviations, with surveillance starting at least 14 days after vaccination.
Posted
Number
Percentage of participants
Day 15 to surveillance cut-off (approximately 6 months)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG0009118
OG0019120
Title
Denominators
Categories
Title
Measurements
OG0000.63
OG0010.95
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
RVE
34.5
2-Sided
95
7.4
53.9
Other
Primary
Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 up to primary surveillance cut-off (approximately 1 year)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Primary
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
Reactogenicity e-diary safety included all participants who received the study intervention and had at least 1 day of e-diary data transferred for reactogenicity.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Primary
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
Reactogenicity e-diary safety set analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Primary
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
Reactogenicity e-diary safety set analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Primary
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
Reactogenicity e-diary safety set analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Primary
Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years
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. Results excluded local reactions and systemic events data.
Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 4 weeks after study vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Primary
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years
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. Results excluded local reactions and systemic events data.
Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 4 weeks after study vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Primary
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years
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. Results excluded local reactions and systemic events data.
Analysis population included all participants who received the study intervention. Data was planned to be analyzed in participants aged >=18 years (combined for 18-64 years and >65 years) as pre-specified in the protocol. The analysis includes participants who received qIRV at either dose level, as well as QIV.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 4 weeks after study vaccination
ID
Title
Description
OG000
qIRV (>=18 Years)
Participants aged >=18 years were randomized to receive a single dose of qIRV dose level 1 (low) and dose level 2 (high) IM on Day 1.
OG001
Licensed QIV (>=18 Years)
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Primary
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years
An 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.
Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Primary
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years
An 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.
Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Primary
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years
An 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.
Analysis population included all participants who received the study intervention. Data was planned to be analyzed in participants aged >=18 years (combined for 18-64 years and >65 years) as pre-specified in the protocol. The analysis includes participants who received qIRV at either dose level, as well as QIV.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
qIRV (>=18 Years)
Participants aged >=18 years were randomized to receive a single dose of qIRV dose level 1 (low) and dose level 2 (high) IM on Day 1.
OG001
Licensed QIV (>=18 Years)
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 to surveillance cut-off (approximately 6 months)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 up to primary surveillance cut-off (approximately 1 year)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
CCI was defined as influenza infection confirmed through culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 to surveillance cut-off (approximately 6 months)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode of CCI With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
CCI was defined as influenza infection confirmed through culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 up to primary surveillance cut-off (approximately 1 year)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified Centers for Disease Control and Prevention (CDC) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 to surveillance cut-off (approximately 6 months)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified CDC Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI defined modified CDC: occurrence (new onset or worsening of preexisting condition) of at least 1 of the following respiratory symptoms concurrently with an oral temperature >37.2 deg C (>99.0 deg F), sore throat or cough. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 up to primary surveillance cut-off (approximately 1 year)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Secondary
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by World Health Organization (WHO) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature >=38.0 deg C (>= 100.4 deg F). Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 to surveillance cut-off (approximately 6 months)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by WHO Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature >=38.0 deg C (>= 100.4 deg F). Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 up to primary surveillance cut-off (approximately 1 year)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: 18-64 Years
Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 to surveillance cut-off (approximately 6 months)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by Central RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: >=65 Years
Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Evaluable efficacy population analyzed.
Posted
Number
Percentage of participants
Day 15 up to primary surveillance cut-off (approximately 1 year)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Geometric mean titers (GMTs) and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. Geometric mean ratios (GMRs) were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 2): eligible participants, received study intervention to which they were randomized, had blood drawn for assay testing within specified time frame, had at least 1 valid, determinate assay result (HAIs determinate assay 2) at 4-week postvaccination, no important protocol deviations. All participants reported under "N" contributed data to table but may not have evaluable data for every row. "n"=number of participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. All participants reported under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row. Here, "Number analyzed" signifies number of participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Here, Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of Participants
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Here, Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years
GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years
GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed" signifies participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 Weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Secondary
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline (Before Vaccination)
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline (Before Vaccination)
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Before vaccination (Baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Before vaccination (Baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Before vaccination (Baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination.
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Before vaccination (Baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
Before vaccination (Baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Before vaccination (Baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed quadrivalent influenza vaccine (QIV) IM per investigational product manual (IPM) on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest.
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 2) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
Before Vaccination (baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Before vaccination (baseline) to 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest.
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
As there was no participant from southern hemisphere aged 18-64 years, no data was collected for this outcome measure. Therefore, there was no analysis performed for this outcome measure.
Posted
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
OG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Evaluable immunogenicity set (Based on HAI Assay 1) analyzed. Participants reported under "Number of Participants Analyzed" contributed data but may not be evaluable for every row. "Number Analyzed": participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline and 4 weeks after vaccination
ID
Title
Description
OG000
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
OG001
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Units
Counts
Participants
OG000
Time Frame
Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination, other AEs: from vaccination 1 up to 4 weeks after last vaccination and All-cause mortality: From vaccination on Day 1 up to 6 months after vaccination.
Description
Same adverse event (preferred term) may appear as both non-SAE and SAE but are distinct events. An adverse event (preferred term) may be categorized as serious in 1 participant and non-serious in another. Safety population included all participants who received the study intervention at the specified dose level. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
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
qIRV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of modRNA qIRV dose level 1 (low) IM on Day 1.
7
9,191
83
9,191
2,607
9,191
EG001
Licensed QIV: 18-64 Years
Participants aged 18-64 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
9
9,197
93
9,197
1,964
9,197
EG002
qIRV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1.
49
13,557
318
13,557
3,091
13,557
EG003
Licensed QIV: >=65 Years
Participants aged >=65 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
46
13,611
296
13,611
1,720
13,611
EG004
qIRV (>=18 Years)
Participants aged >=18 years were randomized to receive a single dose of qIRV dose level 1 (low) and dose level 2 (high) IM on Day 1.
56
22,787
401
22,787
5,698
22,787
EG005
Licensed QIV: >=18 Years
Participants aged >=18 years were randomized to receive a single dose of seasonal licensed QIV IM per IPM on Day 1.
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0011 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Substance use
Social circumstances
MedDRA v26.1
Non-systematic Assessment
EG0001 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Hospitalisation
Surgical and medical procedures
MedDRA v26.1
Non-systematic Assessment
EG0001 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Aortic arteriosclerosis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Aortic dilatation
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0011 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Aortic embolus
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0011 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Aortic intramural haematoma
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Aortic thrombosis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Cyanosis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Haematoma
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Hypertension
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0011 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Hypotension
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0022 affected13,557 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Internal haemorrhage
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0011 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Necrosis ischaemic
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Penetrating atherosclerotic ulcer
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0021 affected13,557 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Scalp haematoma
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Shock
Vascular disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected9,191 at risk
EG0010 affected9,197 at risk
EG0020 affected13,557 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG000355 affected9,191 at risk
EG001332 affected9,197 at risk
EG002272 affected13,557 at risk
EG003237 affected13,611 at risk
EG004627 affected22,787 at risk
EG005569 affected22,808 at risk
Chills (CHILLS)
General disorders
MedDRA v26.1
Systematic Assessment
EG000731 affected9,191 at risk
EG001249 affected9,197 at risk
EG002580 affected13,557 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v26.1
Systematic Assessment
EG0001,579 affected9,191 at risk
EG0011,046 affected9,197 at risk
EG0021,624 affected13,557 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA v26.1
Systematic Assessment
EG000230 affected9,191 at risk
EG001105 affected9,197 at risk
EG002376 affected13,557 at risk
EG003
Injection site pain
General disorders
MedDRA v26.1
Non-systematic Assessment
EG000142 affected9,191 at risk
EG00166 affected9,197 at risk
EG002274 affected13,557 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA v26.1
Systematic Assessment
EG0002,112 affected9,191 at risk
EG0011,284 affected9,197 at risk
EG0022,391 affected13,557 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA v26.1
Systematic Assessment
EG000254 affected9,191 at risk
EG001129 affected9,197 at risk
EG002383 affected13,557 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v26.1
Systematic Assessment
EG000170 affected9,191 at risk
EG00152 affected9,197 at risk
EG002201 affected13,557 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG000493 affected9,191 at risk
EG001208 affected9,197 at risk
EG002407 affected13,557 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG000920 affected9,191 at risk
EG001307 affected9,197 at risk
EG002715 affected13,557 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0001,273 affected9,191 at risk
EG001853 affected9,197 at risk
EG0021,043 affected13,557 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
Pfizer 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.