Influenza, Human
Conditions
Keywords
Grippe, Flu, Influenza, Vaccine, RNA vaccine
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.
Interventions
BIOLOGICALQuadrivalent influenza modRNA vaccine
Quadrivalent influenza modRNA vaccine (single dose)
BIOLOGICALQuadrivalent influenza vaccine
Licensed quadrivalent influenza vaccine (single dose)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participants ≥18 years of age at Visit 1 (Day 1). 2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. 3. 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. 4. 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
1. 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. 2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 3. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 5. Allergy to egg proteins (egg or egg products) or chicken proteins. 6. 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. 7. Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study. 8. 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. 9. 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. 10. Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 15 to surveillance cut-off (approximately 6 months) | 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. |
| 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 | Day 15 up to primary surveillance cut-off (approximately 1 year) | 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. |
| Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years | From Day 1 to Day 7 after study vaccination | 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. |
| Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years | From Day 1 to Day 7 after study vaccination | 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. |
| Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years | From Day 1 to Day 7 after study vaccination | 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. |
| Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years | From Day 1 to Day 7 after study vaccination | 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. |
| Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years | From study vaccination on Day 1 through 4 weeks after study vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. |
| Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years | From study vaccination on Day 1 through 4 weeks after study vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. |
| Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years | From study vaccination on Day 1 through 4 weeks after study vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years | From Day 1 up to 6 months after vaccination | 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. |
| Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years | From Day 1 up to 6 months after vaccination | 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. |
| Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years | From Day 1 up to 6 months after vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4 Weeks after vaccination | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | Before vaccination (Baseline) to 4 weeks after vaccination | GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline). |
| HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | Before vaccination (Baseline) to 4 weeks after vaccination | GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline). |
| 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 | Before vaccination (Baseline) to 4 weeks after vaccination | GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline). |
| HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | Before vaccination (Baseline) to 4 weeks after vaccination | GMFRs were defined as ratios of the results after vaccination to the results before 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 | — |
| 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 | Before vaccination (Baseline) to 4 weeks after vaccination | GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline). |
| 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 | 4 weeks after vaccination | 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 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 | Day 15 to surveillance cut-off (approximately 6 months) | 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. |
| 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 | Before vaccination (baseline) to 4 weeks after vaccination | GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline). |
| 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 | 4 weeks after vaccination | 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 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 | — |
| 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 Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years | Day 15 up to primary surveillance cut-off (approximately 1 year) | 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. |
| 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 | Day 15 to surveillance cut-off (approximately 6 months) | 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. |
| 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 | Day 15 up to primary surveillance cut-off (approximately 1 year) | 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. |
| 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 | Day 15 to surveillance cut-off (approximately 6 months) | 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. |
| 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 | Day 15 up to primary surveillance cut-off (approximately 1 year) | 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. |
| 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 | Day 15 to surveillance cut-off (approximately 6 months) | 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. |
| 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 | Day 15 up to primary surveillance cut-off (approximately 1 year) | 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. |
| 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 | Day 15 to surveillance cut-off (approximately 6 months) | 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. |
| 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 | Day 15 up to primary surveillance cut-off (approximately 1 year) | 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. |
| 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 | 4 Weeks after vaccination | 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. |
| 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 | — |
Countries
Argentina, Chile, New Zealand, Philippines, South Africa, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9,191 |
| 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. | 9,197 |
| qIRV: >=65 Years Participants aged \>=65 years were randomized to receive a single dose of qIRV dose level 2 (high) IM on Day 1. | 13,557 |
| 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. | 13,611 |
| Total | 45,556 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 | 5 |
| Overall Study | Death | 7 | 9 | 49 | 46 |
| Overall Study | Lost to Follow-up | 487 | 427 | 146 | 166 |
| Overall Study | No longer meets eligibility criteria | 0 | 0 | 3 | 2 |
| Overall Study | Not vaccinated | 34 | 53 | 57 | 50 |
| Overall Study | Other (Unspecified) | 8 | 10 | 4 | 2 |
| Overall Study | Physician Decision | 11 | 19 | 8 | 13 |
| Overall Study | Pregnancy | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 1 | 9 | 7 |
| Overall Study | Withdrawal by Subject | 168 | 134 | 331 | 322 |
Baseline characteristics
| Characteristic | qIRV: 18-64 Years | Licensed QIV: 18-64 Years | qIRV: >=65 Years | Licensed QIV: >=65 Years | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.9 Years STANDARD_DEVIATION 13.05 | 43.1 Years STANDARD_DEVIATION 13.07 | 70.9 Years STANDARD_DEVIATION 4.91 | 70.8 Years STANDARD_DEVIATION 4.84 | 59.6 Years STANDARD_DEVIATION 16.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1961 Participants | 1955 Participants | 2041 Participants | 2094 Participants | 8051 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7152 Participants | 7156 Participants | 11409 Participants | 11430 Participants | 37147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 78 Participants | 86 Participants | 107 Participants | 87 Participants | 358 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 73 Participants | 69 Participants | 37 Participants | 42 Participants | 221 Participants |
| Race (NIH/OMB) Asian | 372 Participants | 350 Participants | 1657 Participants | 1691 Participants | 4070 Participants |
| Race (NIH/OMB) Black or African American | 1734 Participants | 1753 Participants | 2567 Participants | 2562 Participants | 8616 Participants |
| Race (NIH/OMB) More than one race | 67 Participants | 88 Participants | 58 Participants | 60 Participants | 273 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 24 Participants | 32 Participants | 64 Participants | 70 Participants | 190 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 141 Participants | 146 Participants | 200 Participants | 194 Participants | 681 Participants |
| Race (NIH/OMB) White | 6780 Participants | 6759 Participants | 8974 Participants | 8992 Participants | 31505 Participants |
| Sex: Female, Male Female | 5395 Participants | 5293 Participants | 7649 Participants | 7665 Participants | 26002 Participants |
| Sex: Female, Male Male | 3796 Participants | 3904 Participants | 5908 Participants | 5946 Participants | 19554 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 9,191 | 9 / 9,197 | 49 / 13,557 | 46 / 13,611 | 56 / 22,787 | 55 / 22,808 |
| other Total, other adverse events | 2,607 / 9,191 | 1,964 / 9,197 | 3,091 / 13,557 | 1,720 / 13,611 | 5,698 / 22,787 | 3,684 / 22,808 |
| serious Total, serious adverse events | 83 / 9,191 | 93 / 9,197 | 318 / 13,557 | 296 / 13,611 | 401 / 22,787 | 389 / 22,808 |
Outcome results
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.
Time frame: From study vaccination on Day 1 through 4 weeks after study vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years | 6.7 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years | 4.9 Percentage of 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.
Time frame: From study vaccination on Day 1 through 4 weeks after study vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years | 7.9 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years | 5.5 Percentage of 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.
Time frame: From study vaccination on Day 1 through 4 weeks after study vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years | 8.7 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years | 5.9 Percentage of participants |
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.
Time frame: From Day 1 to Day 7 after study vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years | 70.1 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years | 43.1 Percentage of participants |
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.
Time frame: From Day 1 to Day 7 after study vaccination
Population: Reactogenicity e-diary safety set analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years | 68.7 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years | 25.8 Percentage of 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.
Time frame: From Day 1 to Day 7 after study vaccination
Population: Reactogenicity e-diary safety set analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years | 65.8 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years | 48.7 Percentage of 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.
Time frame: From Day 1 to Day 7 after study vaccination
Population: Reactogenicity e-diary safety set analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years | 58.6 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years | 34.9 Percentage of participants |
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.
Time frame: Day 15 up to primary surveillance cut-off (approximately 1 year)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.59 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.56 Percentage of participants |
95% CI: [-47.2, 23.8]
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.
Time frame: Day 15 to surveillance cut-off (approximately 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.63 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.95 Percentage of participants |
95% CI: [7.4, 53.9]
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.
Time frame: From Day 1 up to 6 months after vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years | 1.8 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years | 1.7 Percentage of participants |
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.
Time frame: From Day 1 up to 6 months after vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years | 2.3 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years | 2.2 Percentage of participants |
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.
Time frame: From Day 1 up to 6 months after vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years | 0.9 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years | 1.0 Percentage of participants |
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).
Time frame: Before vaccination (Baseline) to 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 4.9 Fold rise |
| qIRV: 18-64 Years | 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 | A/H1N1 | 6.0 Fold rise |
| qIRV: 18-64 Years | 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 | B/Yamagata | 1.7 Fold rise |
| qIRV: 18-64 Years | 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 | B/Victoria | 1.4 Fold rise |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 3.9 Fold rise |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 4.1 Fold rise |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 2.4 Fold rise |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 5.6 Fold rise |
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).
Time frame: Before vaccination (Baseline) to 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | A/H3N2 | 5.4 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | A/H1N1 | 7.5 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | B/Yamagata | 2.2 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | B/Victoria | 1.4 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | B/Victoria | 2.2 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | A/H3N2 | 2.9 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | B/Yamagata | 2.4 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years | A/H1N1 | 4.4 Fold rise |
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.
Time frame: Before vaccination (Baseline) to 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H3N2 | 4.2 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H1N1 | 4.5 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Yamagata | 1.9 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Victoria | 1.8 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Victoria | 2.4 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H3N2 | 1.9 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Yamagata | 1.5 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H1N1 | 2.0 Fold rise |
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).
Time frame: Before vaccination (Baseline) to 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H3N2 | 4.2 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H1N1 | 3.7 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Yamagata | 1.4 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Victoria | 1.6 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Victoria | 2.8 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H3N2 | 2.6 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Yamagata | 1.4 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H1N1 | 2.2 Fold rise |
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years
Time frame: Before vaccination (Baseline) to 4 weeks after vaccination
Population: 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.
Secondary
HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years
Time frame: Before Vaccination (baseline) to 4 weeks after vaccination
Population: 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.
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).
Time frame: Before vaccination (Baseline) to 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H3N2 | 5.5 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H1N1 | 4.8 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Yamagata | 1.8 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Victoria | 2.0 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Victoria | 3.3 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H3N2 | 3.3 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Yamagata | 2.0 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H1N1 | 5.4 Fold rise |
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).
Time frame: Before vaccination (baseline) to 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H3N2 | 6.4 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H1N1 | 6.8 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Yamagata | 2.2 Fold rise |
| qIRV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Victoria | 2.0 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Victoria | 2.5 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H3N2 | 3.0 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Yamagata | 2.1 Fold rise |
| Licensed QIV: 18-64 Years | HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H1N1 | 4.5 Fold rise |
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: A/H3N2 | 32.9 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: A/H3N2 | 224.0 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: A/H1N1 | 14.8 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: A/H1N1 | 129.5 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: B/Yamagata | 16.1 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: B/Yamagata | 40.4 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: B/Victoria | 20.4 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: B/Victoria | 45.9 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: B/Victoria | 55.6 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: A/H3N2 | 30.4 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: B/Yamagata | 16.1 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: A/H3N2 | 96.8 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: B/Victoria | 19.6 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | Baseline: A/H1N1 | 15.0 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: B/Yamagata | 38.0 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | 4 Weeks after vaccination: A/H1N1 | 88.0 Titers |
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
Secondary
HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: A/H3N2 | 84.1 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: A/H3N2 | 460.9 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: A/H1N1 | 10.9 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: A/H1N1 | 73.8 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: B/Yamagata | 35.5 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: B/Yamagata | 70.0 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: B/Victoria | 34.0 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: B/Victoria | 77.9 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: B/Victoria | 124.2 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: A/H3N2 | 82.9 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: B/Yamagata | 37.5 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: A/H3N2 | 272.2 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: B/Victoria | 31.1 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | Baseline: A/H1N1 | 12.2 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: B/Yamagata | 81.4 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years | 4 Weeks after vaccination: A/H1N1 | 92.7 Titers |
Secondary
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | A/H3N2 | 18.2 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | A/H1N1 | 22.7 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | B/Victoria | 10.1 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | B/Yamagata | 22.7 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | B/Victoria | 10.1 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | A/H3N2 | 17.6 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | A/H1N1 | 23.1 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years | B/Yamagata | 22.7 Titers |
Secondary
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H3N2 | 19.7 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H1N1 | 25.2 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Yamagata | 18.1 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Victoria | 20.0 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Victoria | 19.7 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H3N2 | 19.0 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | B/Yamagata | 17.2 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years | A/H1N1 | 24.5 Titers |
Secondary
HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
Time frame: Baseline (Before Vaccination)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | A/H3N2 | 71.2 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | A/H1N1 | 60.2 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | B/Yamagata | 38.7 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | B/Victoria | 47.5 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | B/Victoria | 43.5 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | A/H3N2 | 68.6 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | B/Yamagata | 36.8 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years | A/H1N1 | 58.3 Titers |
Secondary
HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
Time frame: Baseline (Before Vaccination)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | A/H3N2 | 42.9 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | A/H1N1 | 58.0 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | B/Yamagata | 49.2 Titers |
| qIRV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | B/Victoria | 13.0 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | B/Victoria | 13.5 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | A/H3N2 | 42.3 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | B/Yamagata | 46.2 Titers |
| Licensed QIV: 18-64 Years | HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years | A/H1N1 | 50.5 Titers |
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 222.3 Titers |
| qIRV: 18-64 Years | 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 | A/H1N1 | 397.7 Titers |
| qIRV: 18-64 Years | 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 | B/Yamagata | 84.5 Titers |
| qIRV: 18-64 Years | 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 | B/Victoria | 21.3 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 70.6 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 180.4 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 115.9 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 321.7 Titers |
Comparison: A/H3N295% CI: [1.1, 1.38]
Comparison: A/H1N195% CI: [1.1, 1.39]
Comparison: B/Yamagata95% CI: [0.67, 0.8]
Comparison: B/Victoria95% CI: [0.26, 0.35]
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 117.3 Titers |
| qIRV: 18-64 Years | 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 | A/H1N1 | 203.7 Titers |
| qIRV: 18-64 Years | 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 | B/Yamagata | 55.0 Titers |
| qIRV: 18-64 Years | 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 | B/Victoria | 16.7 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 28.7 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 61.1 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 62.4 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 121.2 Titers |
Comparison: A/H3N295% CI: [1.78, 2.07]
Comparison: A/H1N195% CI: [1.55, 1.82]
Comparison: B/Yamagata95% CI: [0.82, 0.94]
Comparison: B/Victoria95% CI: [0.53, 0.63]
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 98.2 Titers |
| qIRV: 18-64 Years | 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 | A/H1N1 | 131.8 Titers |
| qIRV: 18-64 Years | 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 | B/Yamagata | 38.9 Titers |
| qIRV: 18-64 Years | 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 | B/Victoria | 40.1 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 52.9 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 41.3 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 28.6 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 55.6 Titers |
Comparison: A/H3N295% CI: [2.23, 2.54]
Comparison: A/H1N195% CI: [2.22, 2.54]
Comparison: B/Yamagata95% CI: [1.29, 1.43]
Comparison: B/Victoria95% CI: [0.71, 0.81]
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 296.0 Titers |
| qIRV: 18-64 Years | 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 | A/H1N1 | 240.0 Titers |
| qIRV: 18-64 Years | 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 | B/Yamagata | 57.6 Titers |
| qIRV: 18-64 Years | 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 | B/Victoria | 82.1 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 134.8 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 179.8 Titers |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 55.3 Titers |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 140.6 Titers |
Comparison: A/H1N195% CI: [1.51, 1.92]
Comparison: A/H3N295% CI: [1.47, 1.84]
Comparison: B/Yamagata95% CI: [0.95, 1.14]
Comparison: B/Victoria95% CI: [0.54, 0.69]
Secondary
Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
Time frame: 4 weeks after vaccination
Population: 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.
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.
Time frame: 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H3N2 | 81.7 Percentage of participants |
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H1N1 | 77.2 Percentage of participants |
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Yamagata | 29.8 Percentage of participants |
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Victoria | 23.5 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Victoria | 36.9 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H3N2 | 44.9 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | B/Yamagata | 28.8 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years | A/H1N1 | 57.9 Percentage of participants |
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.
Time frame: 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H3N2 | 68.9 Percentage of participants |
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H1N1 | 58.5 Percentage of participants |
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Yamagata | 16.3 Percentage of participants |
| qIRV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Victoria | 21.0 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Victoria | 36.4 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H3N2 | 41.6 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | B/Yamagata | 21.6 Percentage of participants |
| Licensed QIV: 18-64 Years | Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years | A/H1N1 | 58.7 Percentage of participants |
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
Time frame: 4 weeks after vaccination
Population: 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.
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 73.1 Percentage of participants |
| qIRV: 18-64 Years | 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 | A/H1N1 | 78.3 Percentage of participants |
| qIRV: 18-64 Years | 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 | B/Yamagata | 30.0 Percentage of participants |
| qIRV: 18-64 Years | 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 | B/Victoria | 13.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 32.7 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 46.3 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 33.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 51.4 Percentage of participants |
Comparison: A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [23.7, 29.9]
Comparison: A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [23.9, 29.8]
Comparison: B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-6.6, -0.6]
Comparison: B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-21.9, -16.6]
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 66.0 Percentage of participants |
| qIRV: 18-64 Years | 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 | A/H1N1 | 68.4 Percentage of participants |
| qIRV: 18-64 Years | 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 | B/Yamagata | 22.6 Percentage of participants |
| qIRV: 18-64 Years | 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 | B/Victoria | 19.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 33.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 28.1 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 12.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 23.5 Percentage of participants |
Comparison: A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [35.2, 40.5]
Comparison: A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [42.4, 47.4]
Comparison: B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [8.5, 12.8]
Comparison: B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-16.3, -11.3]
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 64.2 Percentage of Participants |
| qIRV: 18-64 Years | 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 | A/H1N1 | 66.1 Percentage of Participants |
| qIRV: 18-64 Years | 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 | B/Yamagata | 13.9 Percentage of Participants |
| qIRV: 18-64 Years | 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 | B/Victoria | 11.4 Percentage of Participants |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 51.8 Percentage of Participants |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 52.8 Percentage of Participants |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 29.2 Percentage of Participants |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 52.5 Percentage of Participants |
Comparison: A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [6.4, 16.4]
Comparison: A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [8.6, 18.6]
Comparison: B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-19.5, -11.2]
Comparison: B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-44.7, -36.1]
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.
Time frame: 4 Weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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 | A/H3N2 | 53.2 Percentage of participants |
| qIRV: 18-64 Years | 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 | A/H1N1 | 50.2 Percentage of participants |
| qIRV: 18-64 Years | 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 | B/Yamagata | 6.4 Percentage of participants |
| qIRV: 18-64 Years | 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 | B/Victoria | 10.9 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | B/Victoria | 33.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | A/H3N2 | 31.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | B/Yamagata | 8.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | A/H1N1 | 24.5 Percentage of participants |
Comparison: A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [16.7, 26.5]
Comparison: A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [20.9, 30.4]
Comparison: B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-4.8, 0.6]
Comparison: B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.95% CI: [-26.7, -18.5]
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.
Time frame: Day 15 up to primary surveillance cut-off (approximately 1 year)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.65 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.62 Percentage of 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.
Time frame: Day 15 to surveillance cut-off (approximately 6 months)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.66 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.98 Percentage of 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.
Time frame: Day 15 up to primary surveillance cut-off (approximately 1 year)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.34 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.36 Percentage of 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.
Time frame: Day 15 to surveillance cut-off (approximately 6 months)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.23 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.34 Percentage of 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.
Time frame: Day 15 up to primary surveillance cut-off (approximately 1 year)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.36 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.30 Percentage of 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.
Time frame: Day 15 to surveillance cut-off (approximately 6 months)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.46 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.61 Percentage of 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.
Time frame: Day 15 up to primary surveillance cut-off (approximately 1 year)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.23 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.22 Percentage of participants |
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.
Time frame: Day 15 to surveillance cut-off (approximately 6 months)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.27 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.35 Percentage of participants |
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.
Time frame: Day 15 to surveillance cut-off (approximately 6 months)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.23 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.34 Percentage of participants |
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.
Time frame: Day 15 up to primary surveillance cut-off (approximately 1 year)
Population: Evaluable efficacy population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| qIRV: 18-64 Years | 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 | 0.34 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 0.36 Percentage of 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 1: 18-64 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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: A/H3N2 | 36.8 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 91.1 Percentage of participants |
| qIRV: 18-64 Years | 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: A/H1N1 | 41.6 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 95.0 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Yamagata | 42.2 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 75.3 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Victoria | 16.3 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 31.9 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 47.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H3N2 | 35.2 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Yamagata | 43.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 75.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Victoria | 15.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H1N1 | 44.9 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 76.7 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 86.8 Percentage of 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 1: >=65 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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: A/H3N2 | 40.4 Percentage of participants |
| qIRV: 18-64 Years | 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: A/H1N1 | 46.4 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 65.1 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 88.3 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Victoria | 36.3 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 91.7 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 63.6 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Yamagata | 31.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 69.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H3N2 | 37.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 64.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H1N1 | 44.4 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 70.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Yamagata | 28.3 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 50.2 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Victoria | 35.2 Percentage of 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
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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: A/H3N2 | 65.0 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 99.2 Percentage of participants |
| qIRV: 18-64 Years | 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: A/H1N1 | 68.0 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 98.4 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Yamagata | 71.3 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 88.7 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Victoria | 25.7 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 38.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 72.7 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H3N2 | 63.1 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Yamagata | 69.3 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 96.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Victoria | 24.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H1N1 | 63.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 93.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 96.6 Percentage of 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: >=65 Years
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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: A/H3N2 | 84.5 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 99.6 Percentage of participants |
| qIRV: 18-64 Years | 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: A/H1N1 | 70.5 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 96.2 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Yamagata | 60.9 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 77.3 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Victoria | 64.4 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 78.7 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Victoria | 89.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H3N2 | 85.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Yamagata | 60.7 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H3N2 | 97.3 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Victoria | 61.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H1N1 | 73.2 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: B/Yamagata | 75.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 Weeks after vaccination: A/H1N1 | 92.1 Percentage of 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
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
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
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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: A/H3N2 | 61.3 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Yamagata | 28.5 Percentage of participants |
| qIRV: 18-64 Years | 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: A/H1N1 | 27.9 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: B/Yamagata | 69.4 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: A/H3N2 | 98.2 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Victoria | 38.1 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: A/H1N1 | 85.6 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: B/Victoria | 69.3 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: A/H1N1 | 77.9 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H3N2 | 58.3 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: A/H3N2 | 89.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H1N1 | 28.5 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: B/Victoria | 73.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Yamagata | 26.7 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: B/Yamagata | 61.9 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Victoria | 34.6 Percentage of 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
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
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
Time frame: Baseline and 4 weeks after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qIRV: 18-64 Years | 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: A/H3N2 | 93.8 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: A/H3N2 | 100.0 Percentage of participants |
| qIRV: 18-64 Years | 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: A/H1N1 | 19.8 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: A/H1N1 | 70.0 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Yamagata | 56.5 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: B/Yamagata | 82.9 Percentage of participants |
| qIRV: 18-64 Years | 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: B/Victoria | 54.8 Percentage of participants |
| qIRV: 18-64 Years | 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 | 4 weeks after vaccination: B/Victoria | 80.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: B/Victoria | 86.9 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H3N2 | 94.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Yamagata | 61.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: A/H3N2 | 99.0 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: B/Victoria | 50.8 Percentage of participants |
| Licensed QIV: 18-64 Years | 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: A/H1N1 | 23.6 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: B/Yamagata | 87.4 Percentage of participants |
| Licensed QIV: 18-64 Years | 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 | 4 weeks after vaccination: A/H1N1 | 76.6 Percentage of participants |