Influenza (Healthy Volunteers)
Conditions
Brief summary
Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations. Secondary Objective: * To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of: * inpatient hospitalization for selected circulatory and respiratory causes * death, either all-cause or cardiovascular or respiratory causes * inpatient hospitalization (using primary and secondary discharge diagnoses) * inpatient hospitalization (using admission diagnoses) * hospital emergency room visits * primary care visits to physician or * major acute cardiovascular events (MACE) * To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups. * To describe the clinical relative effectiveness of QIV-HD as compared to QIV-SD: * by age group and by group with specific comorbidities * for different periods of observation * To describe all serious adverse events (SAEs) (including adverse event of special interest \[AESIs\]) for all subjects in both QIV-HD and QIV-SD groups.
Detailed description
Study duration per participant was 1 day of screening and vaccination. The study was planned to be conducted over a period of 3 influenza seasons beginning in 2019-2020. The vaccination period was from October to December.
Interventions
BIOLOGICALQuadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular
BIOLOGICALStandard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participants, the outcome assessors in the hospitals and outpatient care, the Investigators, and the Sponsor will remain blinded to the vaccine assignment in order to avoid any bias in reporting and evaluating illnesses or SAEs. An unblinded qualified trial staff member will administer the appropriate vaccine.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Aged 65 years or older on the day of inclusion (65 years means from the day of the 65th birthday).
Exclusion criteria
* Participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Previous vaccination against influenza (in the preceding 6 months) with either the study vaccines or another vaccine. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with hospitalizations due to any cardiovascular or respiratory diseases on the basis of International Classification of Diseases, Tenth Revision (ICD-10) codes as per health care professional (HCP) assessment were collected using Finnish health registers and reported in this outcome measure (OM). ICD-10 codes for respiratory system diseases: J00-J06 (acute upper respiratory infections), J09-J18 (influenza & pneumonia), J20-J22 (other acute lower respiratory infections), J40-J47 (chronic lower respiratory diseases), J80-J81 (other respiratory diseases affecting interstitium), J85-J86 (suppurative & necrotic conditions of lower respiratory tract); codes for circulatory diseases: I11 (hypertensive diseases), I20-I25 (ischemic heart diseases), I26-I27 (pulmonary heart disease & diseases of pulmonary circulation), I30, I31, I33, I38-I42, I46-I50 (other forms of heart disease), I63-I67 (cerebrovascular diseases) & I74 (diseases of arteries, arterioles & capillaries). |
| Number of Participants With Primary Discharge Diagnoses For Any Respiratory and Circulatory Systems Diseases Hospitalizations | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with primary discharge diagnoses (final diagnosis given to participant before release from hospital) for any respiratory & circulatory diseases hospitalizations on the basis of ICD-10 codes per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for respiratory system diseases were: J00-J06 (acute upper respiratory infections), J09-J18 (influenza & pneumonia), J20-J22 (other acute lower respiratory infections), J40-J47 (chronic lower respiratory diseases), J80-J81 (respiratory diseases affecting interstitium), J85-J86 (suppurative & necrotic conditions of the lower respiratory tract); and codes for circulatory system diseases were: I11 (hypertensive diseases), I20-I25 (ischemic heart diseases), I26-I27 (pulmonary heart disease & diseases of pulmonary circulation), I30, I31, I33, I38-I42, I46-I50 (other heart disease), I63-I67 (cerebrovascular diseases) and I74 (diseases of arteries, arterioles and capillaries). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with primary admission diagnosis (diagnosis given to the participant at the time of admission to hospital) and secondary admission diagnosis (diagnosis that coexist with the primary admission diagnosis at the time of admission) due to any diseases of respiratory and circulatory system and separately for each disease on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11). |
| Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with primary discharge diagnosis (final diagnosis given to a participant before release from the hospital) and secondary discharge diagnosis (diagnoses that coexist with the primary discharge diagnosis at the time of discharge) due to any diseases of respiratory and circulatory system and separately for each disease on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11). |
| Number of Participants With Hospital Emergency Room Visits | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants reporting hospital emergency room visits due to any diseases of respiratory and circulatory system and separately due to each disease, on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11). |
| Number of Participants With Acute Primary Care Visits to Physician | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants reporting acute primary care visits to physician due to any diseases of the respiratory and circulatory system and separately for each disease, on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11). |
| Number of Participants With Major Acute Cardiovascular Events (MACE) | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Major acute cardiovascular events (MACE) were defined by all of the following outcomes: ischemic heart diseases based on codes I20-I25, non-fatal myocardial infarction based on codes I21-I23, unstable angina based on codes I20 and I25 and fatal or non-fatal cerebral infarction based on code I63. Number of participants with MACE events on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. |
| Percentage of Observed Cardiorespiratory Events During the Assessment Period | 14 to 30 days, 31 to 60 days, 61 to 90 days, 91 to 120 days and 121 days or above | Percentage of observed cardiorespiratory events during the different time durations over the assessment period were reported in this OM. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. International Classification of Primary Care Second Edition (ICPC-2) codes: R72, R74 to R81, R83, R95 and R96; K70, K74 to K80, K82, K84, K87 and K90 to K93. |
| Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with primary discharge diagnoses (final diagnosis given to participant before release from hospital) due to each disease of respiratory and circulatory system on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. The codes selected were pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11). |
| Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with hospitalizations due to any diseases of the respiratory or circulatory system and separately for respiratory and circulatory diseases on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and presented by age groups (65 to 74 years, 75 years and above and 85 years and above) in this OM. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. |
| Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants with hospitalizations due to any diseases of the respiratory or circulatory system and separately for respiratory and circulatory diseases on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and presented by various comorbidities (diabetes, cardiovascular history and chronic lung disease) in this OM. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. |
| Number of Occurrences for Cardiorespiratory Diseases During Influenza Epidemic Period | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | The influenza epidemic period as per Finnish epidemic thresholds was defined as the period where the influenza incidence was high. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85-J86; and codes for any circulatory system diseases were: I11 and I16, I20-I25, I26-I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. ICPC-2 codes: R72, R74 to R81, R83, R95 and R96; K70, K74 to K80, K82, K84, K87 and K90 to K93. |
| Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | SAE: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, was congenital anomaly/ birth defect or was an important medical event. SAR: all noxious and unintended responses to study vaccine related to any dose administered that resulted in death, was life-threatening, required hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, or was congenital anomaly or birth defect. SAR referred to potential causal relationship between study vaccine & SAE, based on assessment of healthcare professional. AESI was defined as one of scientific & medical concern specific to study for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was considered appropriate. Relatedness to study vaccine was based on Investigator's discretion. |
| Number of Participants With Non-fatal SAEs | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | SAEs were defined as any untoward medical occurrence that at any dose was life-threatening, required inpatient hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, was congenital anomaly/ birth defect or was an important medical event. Information on non-fatal SAEs was collected from the health registers. |
| Duration of Cardiorespiratory Hospitalization | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Duration (in days) of cardiorespiratory hospitalization was defined as stop date of event (hospitalization) minus start date of event plus 1. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. |
| Number of Participants With Deaths | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | Number of participants reporting death (all-cause) and due to any diseases of respiratory and circulatory system and separately due to each disease on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. Based on ICD-10 codes, codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85-J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11). |
Countries
Finland
Participant flow
Recruitment details
Study was conducted at a single site in Finland by Finnish Institute for Health and Welfare in collaboration with multiple health stations overseen by public health care centers in Finland. A total of 33096 participants were enrolled, out of which 1 participant withdrew consent prior to randomization. 33093 participants were vaccinated between 04 November 2019 and 23 December 2019. Among these, 16549 participants were vaccinated in the QIV-HD group and 16544 participants in the QIV-SD group.
Pre-assignment details
Study was planned to be conducted over a period of 3 influenza seasons beginning in 2019-2020. Enrollment & data collection were disrupted during the 2020-2021 & 2021-2022 influenza seasons due to worldwide coronavirus disease 2019 (COVID-19). Data collection period was chosen as: from 14 days post-vaccination up to end of May of year following vaccination. Study was terminated prematurely after only 1 influenza season (2019-2020) & thus included only season 2019-2020 assessment.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: QIV-HD Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 16,549 |
| Group 2: QIV-SD Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 16,544 |
| Total | 33,093 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 102 | 92 |
| Overall Study | Randomized but not treated | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Group 1: QIV-HD | Group 2: QIV-SD | Total |
|---|---|---|---|
| Age, Continuous | 72.6 years STANDARD_DEVIATION 5.7 | 72.5 years STANDARD_DEVIATION 5.6 | 72.5 years STANDARD_DEVIATION 5.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8273 Participants | 8241 Participants | 16514 Participants |
| Sex: Female, Male Male | 8276 Participants | 8303 Participants | 16579 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 102 / 16,549 | 92 / 16,544 |
| other Total, other adverse events | 0 / 16,549 | 0 / 16,544 |
| serious Total, serious adverse events | 109 / 16,549 | 98 / 16,544 |
Outcome results
Primary
Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases
Number of participants with hospitalizations due to any cardiovascular or respiratory diseases on the basis of International Classification of Diseases, Tenth Revision (ICD-10) codes as per health care professional (HCP) assessment were collected using Finnish health registers and reported in this outcome measure (OM). ICD-10 codes for respiratory system diseases: J00-J06 (acute upper respiratory infections), J09-J18 (influenza & pneumonia), J20-J22 (other acute lower respiratory infections), J40-J47 (chronic lower respiratory diseases), J80-J81 (other respiratory diseases affecting interstitium), J85-J86 (suppurative & necrotic conditions of lower respiratory tract); codes for circulatory diseases: I11 (hypertensive diseases), I20-I25 (ischemic heart diseases), I26-I27 (pulmonary heart disease & diseases of pulmonary circulation), I30, I31, I33, I38-I42, I46-I50 (other forms of heart disease), I63-I67 (cerebrovascular diseases) & I74 (diseases of arteries, arterioles & capillaries).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases | 257 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases | 272 Participants |
95% CI: [-12.43, 20.66]
Primary
Number of Participants With Primary Discharge Diagnoses For Any Respiratory and Circulatory Systems Diseases Hospitalizations
Number of participants with primary discharge diagnoses (final diagnosis given to participant before release from hospital) for any respiratory & circulatory diseases hospitalizations on the basis of ICD-10 codes per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for respiratory system diseases were: J00-J06 (acute upper respiratory infections), J09-J18 (influenza & pneumonia), J20-J22 (other acute lower respiratory infections), J40-J47 (chronic lower respiratory diseases), J80-J81 (respiratory diseases affecting interstitium), J85-J86 (suppurative & necrotic conditions of the lower respiratory tract); and codes for circulatory system diseases were: I11 (hypertensive diseases), I20-I25 (ischemic heart diseases), I26-I27 (pulmonary heart disease & diseases of pulmonary circulation), I30, I31, I33, I38-I42, I46-I50 (other heart disease), I63-I67 (cerebrovascular diseases) and I74 (diseases of arteries, arterioles and capillaries).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses For Any Respiratory and Circulatory Systems Diseases Hospitalizations | Any diseases of the respiratory system | 88 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses For Any Respiratory and Circulatory Systems Diseases Hospitalizations | Any diseases of the circulatory system | 171 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses For Any Respiratory and Circulatory Systems Diseases Hospitalizations | Any diseases of the respiratory system | 93 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses For Any Respiratory and Circulatory Systems Diseases Hospitalizations | Any diseases of the circulatory system | 184 Participants |
Comparison: Statistical analysis for diseases of respiratory system.95% CI: [-27.99, 30.14]
Comparison: Statistical analysis for diseases of circulatory system.95% CI: [-15.04, 25]
Secondary
Duration of Cardiorespiratory Hospitalization
Duration (in days) of cardiorespiratory hospitalization was defined as stop date of event (hospitalization) minus start date of event plus 1. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants. Here 'overall number of participants analyzed'= participants with available data for this OM.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: QIV-HD | Duration of Cardiorespiratory Hospitalization | 5.0 days |
| Group 2: QIV-SD | Duration of Cardiorespiratory Hospitalization | 5.0 days |
Secondary
Number of Occurrences for Cardiorespiratory Diseases During Influenza Epidemic Period
The influenza epidemic period as per Finnish epidemic thresholds was defined as the period where the influenza incidence was high. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85-J86; and codes for any circulatory system diseases were: I11 and I16, I20-I25, I26-I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. ICPC-2 codes: R72, R74 to R81, R83, R95 and R96; K70, K74 to K80, K82, K84, K87 and K90 to K93.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Data for this outcome measure was not collected and analyzed as influenza epidemic period was not observed before study termination.
Secondary
Number of Participants With Acute Primary Care Visits to Physician
Number of participants reporting acute primary care visits to physician due to any diseases of the respiratory and circulatory system and separately for each disease, on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Any diseases of the circulatory system | 137 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Atrial fibrillation and flutter | 63 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Heart failure | 16 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Cerebral infarction | 2 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Pneumonia | 23 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Influenza and pneumonia | 23 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Acute myocardial infarction | 3 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Influenza | 3 Participants |
| Group 1: QIV-HD | Number of Participants With Acute Primary Care Visits to Physician | Any diseases of the respiratory system | 279 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Influenza | 1 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Any diseases of the respiratory system | 285 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Any diseases of the circulatory system | 120 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Pneumonia | 25 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Heart failure | 19 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Acute myocardial infarction | 5 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Atrial fibrillation and flutter | 53 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Cerebral infarction | 2 Participants |
| Group 2: QIV-SD | Number of Participants With Acute Primary Care Visits to Physician | Influenza and pneumonia | 25 Participants |
Secondary
Number of Participants With Deaths
Number of participants reporting death (all-cause) and due to any diseases of respiratory and circulatory system and separately due to each disease on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. Based on ICD-10 codes, codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85-J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Heart failure | 3 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death (All-cause) | 102 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Acute myocardial infarction | 0 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to any diseases of circulatory system | 19 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Atrial fibrillation and flutter | 0 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Influenza and pneumonia | 3 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Cerebral infarction | 1 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Pneumonia | 3 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to Influenza | 0 Participants |
| Group 1: QIV-HD | Number of Participants With Deaths | Death due to any diseases of respiratory system | 3 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Influenza | 0 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death (All-cause) | 92 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to any diseases of respiratory system | 9 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to any diseases of circulatory system | 16 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Pneumonia | 9 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Heart failure | 1 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Acute myocardial infarction | 4 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Atrial fibrillation and flutter | 0 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Influenza and pneumonia | 9 Participants |
| Group 2: QIV-SD | Number of Participants With Deaths | Death due to Cerebral infarction | 1 Participants |
Secondary
Number of Participants With Hospital Emergency Room Visits
Number of participants reporting hospital emergency room visits due to any diseases of respiratory and circulatory system and separately due to each disease, on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Any diseases of the circulatory system | 158 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Atrial fibrillation and flutter | 109 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Heart failure | 15 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Cerebral infarction | 1 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Pneumonia | 28 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Influenza and pneumonia | 28 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Acute myocardial infarction | 0 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Influenza | 5 Participants |
| Group 1: QIV-HD | Number of Participants With Hospital Emergency Room Visits | Any diseases of the respiratory system | 95 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Influenza | 10 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Any diseases of the respiratory system | 97 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Any diseases of the circulatory system | 158 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Pneumonia | 36 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Heart failure | 11 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Acute myocardial infarction | 0 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Atrial fibrillation and flutter | 118 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Cerebral infarction | 0 Participants |
| Group 2: QIV-SD | Number of Participants With Hospital Emergency Room Visits | Influenza and pneumonia | 36 Participants |
Secondary
Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups
Number of participants with hospitalizations due to any diseases of the respiratory or circulatory system and separately for respiratory and circulatory diseases on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and presented by age groups (65 to 74 years, 75 years and above and 85 years and above) in this OM. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 65 to 74 years: Diseases of respiratory system | 42 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 75 years and above: Diseases of circulatory system | 93 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 75 years and above: Any diseases of respiratory/circulatory system | 137 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 85 years and above: Any diseases of respiratory/circulatory system | 32 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 65 to 74 years: Diseases of circulatory system | 78 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 85 years and above: Diseases of respiratory system | 6 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 75 years and above: Diseases of respiratory system | 46 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 85 years and above: Diseases of circulatory system | 26 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 65 to 74 years: Any diseases of respiratory/circulatory system | 120 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 85 years and above: Diseases of circulatory system | 18 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 65 to 74 years: Any diseases of respiratory/circulatory system | 151 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 65 to 74 years: Diseases of respiratory system | 48 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 65 to 74 years: Diseases of circulatory system | 105 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 75 years and above: Any diseases of respiratory/circulatory system | 121 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 75 years and above: Diseases of respiratory system | 45 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 75 years and above: Diseases of circulatory system | 79 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 85 years and above: Any diseases of respiratory/circulatory system | 32 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: By Age Groups | 85 years and above: Diseases of respiratory system | 15 Participants |
Secondary
Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities
Number of participants with hospitalizations due to any diseases of the respiratory or circulatory system and separately for respiratory and circulatory diseases on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and presented by various comorbidities (diabetes, cardiovascular history and chronic lung disease) in this OM. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of respiratory system with comorbidity of cardiovascular history | 27 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Any diseases of respiratory/circulatory system with comorbidity diabetes | 60 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of circulatory system with comorbidity diabetes | 34 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of respiratory system with comorbidity diabetes | 26 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Any diseases of respiratory/circulatory system with comorbidity of chronic lung disease | 54 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of circulatory system with comorbidity of chronic lung disease | 26 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of respiratory system with comorbidity of chronic lung disease | 28 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Any diseases of respiratory/circulatory system with comorbidity of cardiovascular history | 104 Participants |
| Group 1: QIV-HD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of circulatory system with comorbidity of cardiovascular history | 77 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Any diseases of respiratory/circulatory system with comorbidity of cardiovascular history | 108 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of circulatory system with comorbidity of chronic lung disease | 21 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Any diseases of respiratory/circulatory system with comorbidity diabetes | 63 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of respiratory system with comorbidity of cardiovascular history | 28 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of circulatory system with comorbidity diabetes | 44 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of respiratory system with comorbidity of chronic lung disease | 37 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of respiratory system with comorbidity diabetes | 21 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Diseases of circulatory system with comorbidity of cardiovascular history | 82 Participants |
| Group 2: QIV-SD | Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases: Groups With Specific Comorbidities | Any diseases of respiratory/circulatory system with comorbidity of chronic lung disease | 57 Participants |
Secondary
Number of Participants With Major Acute Cardiovascular Events (MACE)
Major acute cardiovascular events (MACE) were defined by all of the following outcomes: ischemic heart diseases based on codes I20-I25, non-fatal myocardial infarction based on codes I21-I23, unstable angina based on codes I20 and I25 and fatal or non-fatal cerebral infarction based on code I63. Number of participants with MACE events on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Ischaemic heart diseases | 46 Participants |
| Group 1: QIV-HD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Myocardial infarction | 31 Participants |
| Group 1: QIV-HD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Unstable angina | 16 Participants |
| Group 1: QIV-HD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Cerebral infarction | 27 Participants |
| Group 2: QIV-SD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Cerebral infarction | 28 Participants |
| Group 2: QIV-SD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Ischaemic heart diseases | 68 Participants |
| Group 2: QIV-SD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Unstable angina | 30 Participants |
| Group 2: QIV-SD | Number of Participants With Major Acute Cardiovascular Events (MACE) | Myocardial infarction | 40 Participants |
Secondary
Number of Participants With Non-fatal SAEs
SAEs were defined as any untoward medical occurrence that at any dose was life-threatening, required inpatient hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, was congenital anomaly/ birth defect or was an important medical event. Information on non-fatal SAEs was collected from the health registers.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: QIV-HD | Number of Participants With Non-fatal SAEs | 2 Participants |
| Group 2: QIV-SD | Number of Participants With Non-fatal SAEs | 0 Participants |
Secondary
Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases
Number of participants with primary admission diagnosis (diagnosis given to the participant at the time of admission to hospital) and secondary admission diagnosis (diagnosis that coexist with the primary admission diagnosis at the time of admission) due to any diseases of respiratory and circulatory system and separately for each disease on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the circulatory system | 195 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Atrial fibrillation and flutter | 60 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Heart failure | 45 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Cerebral infarction | 22 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Pneumonia | 69 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Influenza and pneumonia | 69 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Acute myocardial infarction | 27 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Influenza | 7 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the respiratory system | 102 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Influenza | 7 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the respiratory system | 110 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the circulatory system | 199 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Pneumonia | 72 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Heart failure | 43 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Acute myocardial infarction | 37 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Atrial fibrillation and flutter | 51 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Cerebral infarction | 34 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Admission Diagnoses for Respiratory and Circulatory Diseases | Influenza and pneumonia | 72 Participants |
Secondary
Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases
Number of participants with primary discharge diagnosis (final diagnosis given to a participant before release from the hospital) and secondary discharge diagnosis (diagnoses that coexist with the primary discharge diagnosis at the time of discharge) due to any diseases of respiratory and circulatory system and separately for each disease on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. Codes for pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the circulatory system | 257 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Atrial fibrillation and flutter | 105 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Heart failure | 46 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Cerebral infarction | 29 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Pneumonia | 72 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Influenza and pneumonia | 72 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Acute myocardial infarction | 38 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Influenza | 9 Participants |
| Group 1: QIV-HD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the respiratory system | 130 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Influenza | 9 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the respiratory system | 143 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Any diseases of the circulatory system | 263 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Pneumonia | 78 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Heart failure | 57 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Acute myocardial infarction | 41 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Atrial fibrillation and flutter | 99 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Cerebral infarction | 34 Participants |
| Group 2: QIV-SD | Number of Participants With Primary and Secondary Discharge Diagnoses for Respiratory and Circulatory Diseases | Influenza and pneumonia | 78 Participants |
Secondary
Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases
Number of participants with primary discharge diagnoses (final diagnosis given to participant before release from hospital) due to each disease of respiratory and circulatory system on the basis of ICD-10 codes as per HCP assessment were collected using Finnish health registers and reported in this OM. The codes selected were pneumonia (J12-J18); heart failure (I50); acute myocardial infarction (I21); atrial fibrillation and flutter (I48); cerebral infarction (I63); influenza and pneumonia (J09-J18) and influenza (J09-J11).
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Acute myocardial infarction | 31 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Cerebral infarction | 27 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Heart failure | 27 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Influenza and pneumonia | 62 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Atrial fibrillation and flutter | 40 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Influenza | 6 Participants |
| Group 1: QIV-HD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Pneumonia | 62 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Influenza | 8 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Pneumonia | 62 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Heart failure | 27 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Acute myocardial infarction | 40 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Atrial fibrillation and flutter | 32 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Cerebral infarction | 28 Participants |
| Group 2: QIV-SD | Number of Participants With Primary Discharge Diagnoses for Various Respiratory and Circulatory Diseases | Influenza and pneumonia | 62 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs)
SAE: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, was congenital anomaly/ birth defect or was an important medical event. SAR: all noxious and unintended responses to study vaccine related to any dose administered that resulted in death, was life-threatening, required hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, or was congenital anomaly or birth defect. SAR referred to potential causal relationship between study vaccine & SAE, based on assessment of healthcare professional. AESI was defined as one of scientific & medical concern specific to study for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was considered appropriate. Relatedness to study vaccine was based on Investigator's discretion.
Time frame: From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | SAE | 109 Participants |
| Group 1: QIV-HD | Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | AESI | 4 Participants |
| Group 1: QIV-HD | Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | SAR | 1 Participants |
| Group 2: QIV-SD | Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | SAE | 98 Participants |
| Group 2: QIV-SD | Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | AESI | 6 Participants |
| Group 2: QIV-SD | Number of Participants With Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), and Adverse Event of Special Interest (AESIs) | SAR | 1 Participants |
Secondary
Percentage of Observed Cardiorespiratory Events During the Assessment Period
Percentage of observed cardiorespiratory events during the different time durations over the assessment period were reported in this OM. The following codes were taken into account: ICD-10 codes for any respiratory system diseases were: J00-J06, J09-J18, J20-J22, J40-J47, J80-J81, J85 and J86; and codes for any circulatory system diseases were: I11, I20-I25, I26, I27, I30, I31, I33, I38-I42, I46-I50, I63-I67 and I74. International Classification of Primary Care Second Edition (ICPC-2) codes: R72, R74 to R81, R83, R95 and R96; K70, K74 to K80, K82, K84, K87 and K90 to K93.
Time frame: 14 to 30 days, 31 to 60 days, 61 to 90 days, 91 to 120 days and 121 days or above
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: QIV-HD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 31 to 60 days | 18.93 percentage of events |
| Group 1: QIV-HD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 91 to 120 days | 19.93 percentage of events |
| Group 1: QIV-HD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 61 to 90 days | 17.20 percentage of events |
| Group 1: QIV-HD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 121 days or above | 32.12 percentage of events |
| Group 1: QIV-HD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 14 to 30 days | 11.83 percentage of events |
| Group 2: QIV-SD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 121 days or above | 31.22 percentage of events |
| Group 2: QIV-SD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 14 to 30 days | 10.20 percentage of events |
| Group 2: QIV-SD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 31 to 60 days | 19.44 percentage of events |
| Group 2: QIV-SD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 61 to 90 days | 20.49 percentage of events |
| Group 2: QIV-SD | Percentage of Observed Cardiorespiratory Events During the Assessment Period | 91 to 120 days | 18.65 percentage of events |