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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001401-25 | EudraCT Number | ||
| U1111-1217-2654 | Other Identifier | UTN |
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Enrollment terminated due to the COVID-19 pandemic
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: QIV-HD | Experimental | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
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| Group 2: QIV-SD | Active Comparator | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 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). | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion criteria:
- Aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday).
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 2469999 | Tampere | 33520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38569647 | Derived | Palmu AA, Pepin S, Syrjanen RK, Mari K, Mallett Moore T, Jokinen J, Nieminen H, Kilpi T, Samson SI, De Bruijn I. High-Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults. Influenza Other Respir Viruses. 2024 Apr;18(4):e13270. doi: 10.1111/irv.13270. | |
| 33722585 | Derived |
| Label | URL |
|---|---|
| QHD00012 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: QIV-HD | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
| FG001 | Group 2: QIV-SD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2020 | Mar 21, 2023 |
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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.
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| Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular |
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| 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 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). | 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 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). | 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 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). | 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 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). | 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 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). | 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 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. | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
| 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. | 14 to 30 days, 31 to 60 days, 61 to 90 days, 91 to 120 days and 121 days or above |
| 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. | 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 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. | 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 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. | 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 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. | 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 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. | 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 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. | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
| Hollingsworth R, Palmu A, Pepin S, Dupuy M, Shrestha A, Jokinen J, Syrjanen R, Nealon J, Samson S, De Bruijn I. Effectiveness of the quadrivalent high-dose influenza vaccine for prevention of cardiovascular and respiratory events in people aged 65 years and above: Rationale and design of a real-world pragmatic randomized clinical trial. Am Heart J. 2021 Jul;237:54-61. doi: 10.1016/j.ahj.2021.03.007. Epub 2021 Mar 13. |
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all vaccinated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: QIV-HD | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. |
| BG001 | Group 2: QIV-SD | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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). | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Analysis was performed on all vaccinated participants. | Posted | Number | percentage of events | 14 to 30 days, 31 to 60 days, 61 to 90 days, 91 to 120 days and 121 days or above |
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| 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. | Analysis was performed on all vaccinated participants. Here 'overall number of participants analyzed'= participants with available data for this OM. | Posted | Median | Full Range | days | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Data for this outcome measure was not collected and analyzed as influenza epidemic period was not observed before study termination. | Posted | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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| 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. | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) |
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Reported adverse events data was collected from 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)
Analysis was performed on all vaccinated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group1: QIV-HD | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 102 | 16,549 | 109 | 16,549 | 0 | 16,549 |
| EG001 | Group 2: QIV-SD | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 92 | 16,544 | 98 | 16,544 | 0 | 16,544 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Congestive Cardiomyopathy | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Hypertensive Heart Disease | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Gastrointestinal Ulcer Haemorrhage | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Mallory-Weiss Syndrome | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Drowning | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Cirrhosis Alcoholic | Hepatobiliary disorders | MedDra 24.1 | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Pneumonia Klebsiella | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
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| Suspected Covid-19 | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
| |
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
| |
| Exposure To Extreme Temperature | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
| |
| Post Procedural Complication | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
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| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDra 24.1 | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDra 24.1 | Systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Appendix Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Biliary Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Brain Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Bronchial Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Bronchioloalveolar Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Diffuse Large B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Gastrointestinal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Gingival Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Haematopoietic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Malignant Neoplasm Of Unknown Primary Site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Malignant Neoplasm Papilla Of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Malignant Respiratory Tract Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Ovarian Epithelial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Peripheral T-Cell Lymphoma Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Small Intestine Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Spinal Cord Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Amyotrophic Lateral Sclerosis | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Bell's Palsy | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Dementia Alzheimer's Type | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Parkinson's Disease | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Thrombotic Cerebral Infarction | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDra 24.1 | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDra 24.1 | Systematic Assessment |
| |
| Hypertensive Nephropathy | Renal and urinary disorders | MedDra 24.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Hypersensitivity Vasculitis | Skin and subcutaneous tissue disorders | MedDra 24.1 | Systematic Assessment |
| |
| Physical Assault | Social circumstances | MedDra 24.1 | Systematic Assessment |
| |
| Aortic Aneurysm Rupture | Vascular disorders | MedDra 24.1 | Systematic Assessment |
| |
| Aortic Dissection Rupture | Vascular disorders | MedDra 24.1 | Systematic Assessment |
| |
| Aortic Thrombosis | Vascular disorders | MedDra 24.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDra 24.1 | Systematic Assessment |
|
Not provided
COVID-19 severely impacted the study resulting in low influenza circulation and disruption of trial recruitment for subsequent seasons (no enrollment done for seasons 2020-21 & 2021-22). Moreover, the events collected as primary outcomes could have been driven by COVID cases, diluting the effect of influenza vaccines on such events. The study was prematurely terminated.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2022 | Mar 21, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
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