Relative Effectiveness of a High-Dose Quadrivalent Influenza Vaccine Versus a Standard-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 33,096
- Locations
- 1
- Primary Endpoint
- Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, 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 Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD) (Biological)
Group 2: QIV-SD
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
Intervention: Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD) (Biological)
Outcomes
Primary Outcomes
Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases
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)
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
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)
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 Outcomes
- 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 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 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 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 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 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 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 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))
- 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)
- 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))
- 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))
- 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))
- 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))
- 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))