Influenza, Pneumonia, Lower Respiratory Tract Infection, Acute Myocardial Infarction, Congestive Heart Failure, Stroke
Conditions
Keywords
influenza, vaccine effectiveness
Brief summary
The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.
Interventions
BIOLOGICALFlublok Quadrivalent
Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs.
BIOLOGICALStandard Dose Inactivated Influenza Vaccine (SD-IIV)
For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.
Sponsors
Sanofi Pasteur, a Sanofi Company
Kaiser Permanente
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of ≥18 and \<65 years at the time of influenza vaccination * Receive either Flublok Quadrivalent vaccine or standard dose inactivated influenza vaccine at a Kaiser Permanente Northern California facility during the study period from August 2018 through April 2020
Exclusion criteria
* Children \<18 years old * Adults ≥65 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI) | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza) |
| Number of Adults 18-49 Years Old With All-Cause-Hospitalizations | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations |
| Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 18-49 Years Old With All-Cause Mortality | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality |
| Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI) | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza) |
| Number of Adults 50-64 Years Old With All-Cause-Hospitalizations | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations |
| Number of Adults 50-64 Years Old With All-Cause Mortality | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality |
| Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
| Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza | Up to 8 months | Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flublok Recipients Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.
Flublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs. | 632,962 |
| SD-IIV Recipients Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).
Standard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent. | 997,366 |
| Total | 1,630,328 |
Baseline characteristics
| Characteristic | Flublok Recipients | Total | SD-IIV Recipients |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 632962 Participants | 1630328 Participants | 997366 Participants |
| Body mass index 0 - < 18.5 kg/m² | 7819 Participants | 20130 Participants | 12311 Participants |
| Body mass index 18.5 - < 25 kg/m² | 188431 Participants | 494625 Participants | 306194 Participants |
| Body mass index 25 - < 30 kg/m² | 206663 Participants | 530287 Participants | 323624 Participants |
| Body mass index ≥ 30 kg/m² | 209817 Participants | 531424 Participants | 321607 Participants |
| Body mass index None | 20232 Participants | 53862 Participants | 33630 Participants |
| Charlson Comorbidity Index CCI=1 | 81980 Participants | 204542 Participants | 122562 Participants |
| Charlson Comorbidity Index CCI≥2 | 42864 Participants | 104789 Participants | 61925 Participants |
| Charlson Comorbidity Index No Charlson comorbidities | 508118 Participants | 1320997 Participants | 812879 Participants |
| History of asthma | 86127 Participants | 218677 Participants | 132550 Participants |
| History of chronic obstructive pulmonary disease | 6174 Participants | 14737 Participants | 8563 Participants |
| History of coronary heart disease | 11947 Participants | 28849 Participants | 16902 Participants |
| History of diabetes | 67026 Participants | 164218 Participants | 97192 Participants |
| Number of inpatient stays in prior year 0 | 573712 Participants | 1476077 Participants | 902365 Participants |
| Number of inpatient stays in prior year 1 | 44860 Participants | 116068 Participants | 71208 Participants |
| Number of inpatient stays in prior year 2 | 9707 Participants | 25603 Participants | 15896 Participants |
| Number of inpatient stays in prior year 3 | 2885 Participants | 7620 Participants | 4735 Participants |
| Number of inpatient stays in prior year ≥4 | 1798 Participants | 4960 Participants | 3162 Participants |
| Number of weeks with outpatient visits in prior year 0 | 57602 Participants | 149951 Participants | 92349 Participants |
| Number of weeks with outpatient visits in prior year 1-3 | 270701 Participants | 697744 Participants | 427043 Participants |
| Number of weeks with outpatient visits in prior year 4-7 | 165444 Participants | 422409 Participants | 256965 Participants |
| Number of weeks with outpatient visits in prior year ≥8 | 139215 Participants | 360224 Participants | 221009 Participants |
| Prior membership 1 to <2 years | 62407 Participants | 162722 Participants | 100315 Participants |
| Prior membership <1 year | 78004 Participants | 205164 Participants | 127160 Participants |
| Prior membership 2 to <3 years | 52678 Participants | 137616 Participants | 84938 Participants |
| Prior membership 3 to <4 years | 45919 Participants | 119947 Participants | 74028 Participants |
| Prior membership 4 to <5 years | 41545 Participants | 107837 Participants | 66292 Participants |
| Prior membership ≥5 years | 352409 Participants | 897042 Participants | 544633 Participants |
| Race/Ethnicity, Customized Asian | 159104 Participants | 414112 Participants | 255008 Participants |
| Race/Ethnicity, Customized Black | 27601 Participants | 73275 Participants | 45674 Participants |
| Race/Ethnicity, Customized Multiracial | 16229 Participants | 42175 Participants | 25946 Participants |
| Race/Ethnicity, Customized Native American | 2908 Participants | 7543 Participants | 4635 Participants |
| Race/Ethnicity, Customized Pacific Islander | 4824 Participants | 12323 Participants | 7499 Participants |
| Race/Ethnicity, Customized Unknown/Other | 147179 Participants | 385213 Participants | 238034 Participants |
| Race/Ethnicity, Customized White | 275117 Participants | 695687 Participants | 420570 Participants |
| Receipt of influenza vaccine in previous year | 414500 Participants | 1054763 Participants | 640263 Participants |
| Region of Enrollment United States | 632962 participants | 1630328 participants | 997366 participants |
| Sex: Female, Male Female | 363921 Participants | 949403 Participants | 585482 Participants |
| Sex: Female, Male Male | 269041 Participants | 680925 Participants | 411884 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 352 / 632,962 | 501 / 997,366 |
| other Total, other adverse events | 0 / 632,962 | 0 / 997,366 |
| serious Total, serious adverse events | 0 / 632,962 | 0 / 997,366 |
Outcome results
Primary
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests | 559 participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests | 925 participants |
p-value: <0.0595% CI: [0.76, 0.94]Regression, Cox
Secondary
Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events | 631 Participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events | 890 Participants |
p-value: <0.0595% CI: [0.88, 1.08]Regression, Cox
Secondary
Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia | 106 Participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia | 183 Participants |
p-value: <0.0595% CI: [0.66, 1.06]Regression, Cox
Secondary
Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza | 95 participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza | 153 participants |
p-value: <0.0595% CI: [0.65, 1.09]Regression, Cox
Secondary
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests | 522 participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests | 862 participants |
p-value: <0.0595% CI: [0.76, 0.94]Regression, Cox
Secondary
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests | 37 participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests | 64 participants |
p-value: <0.0595% CI: [0.6, 1.34]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events | 133 Participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events | 208 Participants |
p-value: <0.0595% CI: [0.76, 1.12]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia | 37 Participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia | 49 Participants |
p-value: <0.0595% CI: [0.75, 1.8]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza | 48 participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza | 88 participants |
p-value: <0.0595% CI: [0.75, 1.52]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old With All-Cause-Hospitalizations
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old With All-Cause-Hospitalizations | 1858 Participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old With All-Cause-Hospitalizations | 2950 Participants |
p-value: <0.0595% CI: [0.94, 1.06]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old With All-Cause Mortality
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old With All-Cause Mortality | 66 Participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old With All-Cause Mortality | 79 Participants |
p-value: <0.0595% CI: [1.06, 2]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI)
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI) | 2904 Participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI) | 5434 Participants |
p-value: <0.0595% CI: [0.85, 0.93]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests | 682 participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests | 1282 participants |
p-value: <0.0595% CI: [0.82, 0.99]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests | 146 participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests | 231 participants |
p-value: <0.0595% CI: [0.95, 1.43]Regression, Cox
Other Pre-specified
Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Time frame: Up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok Recipients | Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests | 827 participants |
| SD-IIV Recipients | Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests | 1510 participants |
p-value: <0.0595% CI: [0.86, 1.02]Regression, Cox
Other Pre-specified
Number of Adults 50-64 Years Old With All-Cause-Hospitalizations
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old With All-Cause-Hospitalizations | 4308 Participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old With All-Cause-Hospitalizations | 6005 Participants |
p-value: <0.0595% CI: [-2.2, 5.5]Regression, Cox
Other Pre-specified
Number of Adults 50-64 Years Old With All-Cause Mortality
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old With All-Cause Mortality | 286 Participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old With All-Cause Mortality | 422 Participants |
p-value: <0.0595% CI: [-5.4, 22.1]Regression, Cox
Other Pre-specified
Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI)
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)
Time frame: Up to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flublok Recipients | Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI) | 1826 Participants |
| SD-IIV Recipients | Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI) | 2871 Participants |
p-value: <0.0595% CI: [0.95, 1.06]Regression, Cox