Influenza
Conditions
Brief summary
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
Interventions
1 dose approximately 0.5 mL of aQIV
BIOLOGICALNon-Influenza Comparator (Boostrix)
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males and females ≥ 65 years old who are healthy or have co-morbidities 2. Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Ability to attend all scheduled visits and to comply with study procedures
Exclusion criteria
1. Hypersensitivity, including allergy to any component of vaccines foreseen in this study 2. Abnormal function of the immune system. 3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study. 4. Additional eligibility criteria may be discussed by contacting the site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The primary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the primary endpoint. |
| Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Day 1 through Day 7 | Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination. |
| Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs) | Within 30 days after of first occurrence RT-PCR confirmed Influenza | Safety of vaccination was assessed in terms of percentage of subjects reporting medically attended AEs within 30 days after of first occurrence RT-PCR confirmed influenza. |
| Safety Endpoint: Percentages of Subjects With Any Unsolicited AE | Day 1 through Day 366 | Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination. |
| Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Day 1 to Day 366 | Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs up to 366 days after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint. |
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint. |
| Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | Days 1 and 22 | The log-transformed antibody titers (GMT) at Day 1 and Day 22 were evaluated using an analysis of covariance (ANCOVA) model including factors for site/country, pre-vaccination titer, age, and comorbidity. |
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary efficacy endpoint. |
| Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | Day 22 | The percentage of subjects vaccinated with aQIV with a HI antibody titers ≥1:40 was assessed for each of the 4 strains Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for percent of subjects with HI antibody titer ≥1:40 met or exceeded 60% at Day 22. |
| Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | Day 22 | The percentage of subjects achieving SCR at Day 22 was assessed for each of the 4 strains. SCR is defined as HI titer ≥1:40 for subjects seronegative at baseline (HI titer \<1:10) or a minimum 4-fold increase in HI titer for subjects seropositive at baseline (HI titer ≥1:10) on Day 22. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody SCR met or exceeded 30% at Day 22. |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | Day 22/Day 1 | The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1). |
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint. |
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint. |
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition. | Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint. |
| Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition. | Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer | The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint. |
Countries
Bulgaria, Colombia, Czechia, Estonia, Latvia, Lithuania, Malaysia, Philippines, Poland, Romania, Thailand, Turkey (Türkiye)
Participant flow
Recruitment details
The study enrolled male and female adults ≥ 65 years old who were healthy or had co-morbidities.
Pre-assignment details
Screening criteria applied.
Participants by arm
| Arm | Count |
|---|---|
| aQIV Subjects received one dose of aQIV vaccine | 3,394 |
| Non-influenza Comparator Vaccine Subjects received one dose of non-influenza comparator vaccine (Boostrix) | 3,396 |
| Total | 6,790 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Death | 33 | 34 |
| Overall Study | Lost to Follow-up | 21 | 19 |
| Overall Study | Other Reason or Unspecified | 2 | 1 |
| Overall Study | Protocol Violation | 6 | 5 |
| Overall Study | Withdrawal by Subject | 66 | 61 |
Baseline characteristics
| Characteristic | Total | aQIV | Non-influenza Comparator Vaccine |
|---|---|---|---|
| Age, Continuous | 71.9 years STANDARD_DEVIATION 5.44 | 71.9 years STANDARD_DEVIATION 5.53 | 71.8 years STANDARD_DEVIATION 5.36 |
| Age, Customized 65 to 74 years | 4822 Participants | 2416 Participants | 2406 Participants |
| Age, Customized 75 to 84 years | 1821 Participants | 893 Participants | 928 Participants |
| Age, Customized . 85 years | 147 Participants | 85 Participants | 62 Participants |
| Body Mass Index | 27.00 kg/m^2 STANDARD_DEVIATION 4.992 | 27.05 kg/m^2 STANDARD_DEVIATION 4.989 | 26.96 kg/m^2 STANDARD_DEVIATION 4.995 |
| Comorbidity Score < 50 | 4946 Participants | 2472 Participants | 2474 Participants |
| Comorbidity Score ≥ 50 | 1844 Participants | 922 Participants | 922 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1222 Participants | 615 Participants | 607 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5552 Participants | 2773 Participants | 2779 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 6 Participants | 10 Participants |
| Previous Seasonal Influenza Vaccine in the Past 5 Years No | 4778 Participants | 2403 Participants | 2375 Participants |
| Previous Seasonal Influenza Vaccine in the Past 5 Years Yes | 2012 Participants | 991 Participants | 1021 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 121 participants | 62 participants | 59 participants |
| Race/Ethnicity, Customized Asian | 2298 participants | 1139 participants | 1159 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Other | 1099 participants | 550 participants | 549 participants |
| Race/Ethnicity, Customized White | 3271 participants | 1642 participants | 1629 participants |
| Region of Enrollment Bulgaria | 366 participants | 183 participants | 183 participants |
| Region of Enrollment Colombia | 1224 participants | 613 participants | 611 participants |
| Region of Enrollment Czechia | 366 participants | 182 participants | 184 participants |
| Region of Enrollment Estonia | 641 participants | 324 participants | 317 participants |
| Region of Enrollment Latvia | 282 participants | 142 participants | 140 participants |
| Region of Enrollment Lithuania | 447 participants | 223 participants | 224 participants |
| Region of Enrollment Malaysia | 899 participants | 446 participants | 453 participants |
| Region of Enrollment Philippines | 910 participants | 453 participants | 457 participants |
| Region of Enrollment Poland | 719 participants | 361 participants | 358 participants |
| Region of Enrollment Romania | 356 participants | 180 participants | 176 participants |
| Region of Enrollment Thailand | 490 participants | 242 participants | 248 participants |
| Region of Enrollment Turkey | 90 participants | 45 participants | 45 participants |
| Sex: Female, Male Female | 4194 Participants | 2105 Participants | 2089 Participants |
| Sex: Female, Male Male | 2596 Participants | 1289 Participants | 1307 Participants |
| Smoking Status Not smoking | 6130 Participants | 3069 Participants | 3061 Participants |
| Smoking Status Smoking | 660 Participants | 325 Participants | 335 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 33 / 3,380 | 34 / 3,377 |
| other Total, other adverse events | 227 / 665 | 218 / 667 |
| serious Total, serious adverse events | 238 / 3,380 | 234 / 3,377 |
Outcome results
Primary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition.
The primary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the primary endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. | 122 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. | 151 Number of cases |
Comparison: The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%97.45% CI: [-5.27, 38.91]Regression, Cox
Primary
Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs)
Safety of vaccination was assessed in terms of percentage of subjects reporting medically attended AEs within 30 days after of first occurrence RT-PCR confirmed influenza.
Time frame: Within 30 days after of first occurrence RT-PCR confirmed Influenza
Population: UNSOLICITED SAFETY SET - consisting of treated subjects with unsolicited AE data was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs) | 0.7 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs) | 0.4 Percentage of subjects |
Primary
Safety Endpoint: Percentages of Subjects With Any Unsolicited AE
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Time frame: Day 1 through Day 366
Population: UNSOLICITED SAFETY SET - treated subjects with unsolicited AE data was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Safety Endpoint: Percentages of Subjects With Any Unsolicited AE | 21.5 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentages of Subjects With Any Unsolicited AE | 21.2 Percentage of subjects |
Primary
Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI)
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs up to 366 days after vaccination.
Time frame: Day 1 to Day 366
Population: UNSOLICITED SAFETY SET - treated subjects with unsolicited AE data was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any related SAE | 0.0 Percentage of subjects |
| aQIV | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any NOCD | 9.5 Percentage of subjects |
| aQIV | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any unsolicited AEs leading to withdrawal | 1.1 Percentage of subjects |
| aQIV | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any AESI | 0.1 Percentage of subjects |
| aQIV | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any unsolicited SAE | 7.0 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any AESI | 0.2 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any unsolicited SAE | 6.9 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any related SAE | 0.0 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any unsolicited AEs leading to withdrawal | 1.1 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) | Any NOCD | 9.0 Percentage of subjects |
Primary
Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE)
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination.
Time frame: Day 1 through Day 7
Population: SOLICITED SAFETY SET = randomly selected subset of all treated subjects, with solicited safety assessments beyond 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Any solicited AE | 34.3 Percentage of subjects |
| aQIV | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Any local solicited AE | 24.4 Percentage of subjects |
| aQIV | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Any systemic solicited AE | 19.2 Percentage of subjects |
| aQIV | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Other | 6.2 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Other | 3.9 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Any solicited AE | 32.2 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Any systemic solicited AE | 16.3 Percentage of subjects |
| Non-influenza Comparator Vaccine | Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) | Any local solicited AE | 19.6 Percentage of subjects |
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. | 5 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. | 13 Number of cases |
95% CI: [-7.98, 86.28]Regression, Cox
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. | 7 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. | 14 Number of cases |
Comparison: The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%95% CI: [-24.03, 79.79]Regression, Cox
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. | 39 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. | 53 Number of cases |
95% CI: [-11.71, 51.13]Regression, Cox
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. | 51 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. | 67 Number of cases |
95% CI: [-9.69, 47.05]Regression, Cox
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Time frame: Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition. | 44 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition. | 66 Number of cases |
95% CI: [2.56, 54.57]Regression, Cox
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition. | 58 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition. | 81 Number of cases |
95% CI: [0.05, 49.08]Regression, Cox
Secondary
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary efficacy endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition. | 83 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition. | 121 Number of cases |
95% CI: [10.23, 48.67]Regression, Cox
Secondary
Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT)
The log-transformed antibody titers (GMT) at Day 1 and Day 22 were evaluated using an analysis of covariance (ANCOVA) model including factors for site/country, pre-vaccination titer, age, and comorbidity.
Time frame: Days 1 and 22
Population: The FAS Immunogenicity, consisting of all randomized subjects who received a study treatment, and provided immunogenicity data at Days 1 and 22, was used for analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H1N1 Day 1 | 31.86 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H1N1 Day 22 | 438.79 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H3N2 Day 1 | 28.31 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H3N2 Day 22 | 572.80 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Yamagata Day 1 | 13.83 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Yamagata Day 22 | 86.77 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Victoria Day 1 | 12.77 titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Victoria Day 22 | 104.26 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Victoria Day 22 | 11.25 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H1N1 Day 1 | 36.19 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Yamagata Day 1 | 13.13 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H1N1 Day 22 | 29.43 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Victoria Day 1 | 12.26 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H3N2 Day 1 | 27.56 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | B/Yamagata Day 22 | 12.49 titer |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) | A/H3N2 Day 22 | 27.06 titer |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1).
Time frame: Day 22/Day 1
Population: The FAS Immunogenicity, consisting of all randomized subjects who received a study treatment, and provided immunogenicity data at Days 1 and 22, was used for analysis GMR B/Vic: 0.94 to )
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | A/H1N1 | 14.17 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | A/H3N2 | 22.65 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | B/Yamagata | 6.58 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | B/Victoria | 8.59 ratio |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | B/Victoria | 0.94 ratio |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | A/H1N1 | 0.89 ratio |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | B/Yamagata | 0.97 ratio |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer | A/H3N2 | 1.08 ratio |
Secondary
Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR)
The percentage of subjects achieving SCR at Day 22 was assessed for each of the 4 strains. SCR is defined as HI titer ≥1:40 for subjects seronegative at baseline (HI titer \<1:10) or a minimum 4-fold increase in HI titer for subjects seropositive at baseline (HI titer ≥1:10) on Day 22. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody SCR met or exceeded 30% at Day 22.
Time frame: Day 22
Population: analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | A/H1N1 | 78.0 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | A/H3N2 | 84.6 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | B/Yamagata | 60.8 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | B/Victoria | 65.5 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | B/Victoria | 2.1 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | A/H1N1 | 2.1 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | B/Yamagata | 3.6 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) | A/H3N2 | 3.9 Percentage of subjects |
Secondary
Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40
The percentage of subjects vaccinated with aQIV with a HI antibody titers ≥1:40 was assessed for each of the 4 strains Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for percent of subjects with HI antibody titer ≥1:40 met or exceeded 60% at Day 22.
Time frame: Day 22
Population: The FAS Immunogenicity, consisting of all randomized subjects who received a study treatment, and provided immunogenicity data at Days 1 and 22, was used for analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | A/H1N1 | 96.2 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | A/H3N2 | 95.6 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | B/Yamagata | 79.2 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | B/Victoria | 81.6 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | B/Victoria | 18.4 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | A/H1N1 | 46.7 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | B/Yamagata | 21.5 Percentage of subjects |
| Non-influenza Comparator Vaccine | Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 | A/H3N2 | 41.7 Percentage of subjects |
Post Hoc
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using WHO ILI Definition.
The post-hoc efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using WHO ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the post-hoc endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using WHO ILI Definition. | 2 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using WHO ILI Definition. | 8 Number of cases |
95% CI: [-17.93, 94.68]Regression, Cox
Post Hoc
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using WHO ILI Definition.
The post-hoc efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using WHO ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the post-hoc endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using WHO ILI Definition. | 16 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using WHO ILI Definition. | 37 Number of cases |
95% CI: [22.73, 76.09]Regression, Cox
Post Hoc
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using WHO ILI Definition
The post-hoc efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using WHO ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the post-hoc endpoint.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using WHO ILI Definition | 18 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using WHO ILI Definition | 45 Number of cases |
95% CI: [31.19, 76.94]Regression, Cox
Post Hoc
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using WHO ILI Definition.
The post-hoc efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using WHO ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the post-hoc efficacy endpoint
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Population: The Full Analysis Set (FAS) Efficacy, consisting of all randomized subjects who received a study treatment, were under observation for at least 21 days post-vaccination and provided efficacy data, was used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using WHO ILI Definition. | 39 Number of cases |
| Non-influenza Comparator Vaccine | Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using WHO ILI Definition. | 79 Number of cases |
95% CI: [28.21, 66.67]Regression, Cox