Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older

Relative Effectiveness of a High-Dose Quadrivalent Influenza Vaccine versus a Standard-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001401-25-FI

Enrollment

121000

Registered

2019-07-24

Start date

2019-09-27

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza infection in adults from 65 years of age and older MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Efluelda Product Name: quadrivalent influenza vaccine high dose Product Code: 522 Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: INFLUENZA VACCINE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 121000

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main 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 effectivenes 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 ;Primary end point(s): 1 - Number of unscheduled cardiovascular or respiratory inpatient hospitalizations First occurrence of an unscheduled cardiovascular or respiratory inpatient hospitalization will be considered 2 - Number of inpatient hospitalizations with primary discharge diagnosis (for circulatory and respiratory systems diseases only) Inpatient hospitalizations with primary discharge diagnosis (using International Classification of Diseases, Tenth Revision [ICD-10] codes) for the following diseases will be considered: - Diseases of the circulatory system - Diseases of the respiratory system ;Timepoint(s) of evaluation of this end point: [1] , [2] : From 14 days after vaccination to 31 May of the year following the vaccination	—

Measure

Time frame

Main 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 effectivenes 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 ;Primary end point(s): 1 - Number of unscheduled cardiovascular or respiratory inpatient hospitalizations First occurrence of an unscheduled cardiovascular or respiratory inpatient hospitalization will be considered 2 - Number of inpatient hospitalizations with primary discharge diagnosis (for circulatory and respiratory systems diseases only) Inpatient hospitalizations with primary discharge diagnosis (using International Classification of Diseases, Tenth Revision [ICD-10] codes) for the following diseases will be considered: - Diseases of the circulatory system - Diseases of the respiratory system ;Timepoint(s) of evaluation of this end point: [1] , [2] : From 14 days after vaccination to 31 May of the year following the vaccination

—

Secondary

Measure	Time frame
Secondary end point(s): 1 - Number of inpatient hospitalizations with primary discharge diagnosis Inpatient hospitalization with primary discharge diagnosis (using ICD-10 codes) for the following diseases will be considered: - Diseases of the respiratory system - Diseases of the circulatory system - Pneumonia - Heart failure - Acute myocardial infarction - Atrial Fibrillation - Stroke - Influenza and pneumonia 2 - Number of deaths Death all-cause and based on the diseases listed in first secondary endpoint will be considered 3 - Number of inpatient hospitalizations with primary and secondary admission and discharge diagnoses Inpatient hospitalization with primary discharge and second admission discharge diagnosis based on the diseases listed in first secondary endpoint will be considered 4 - Number of hospital emergency room visits Hospital emergency room visits based on the diseases listed in first secondary endpoint will be considered 5 - Number of acute primary care visits to physician Acute primary care visits to physician based on the diseases listed in first secondary endpoint (using ICD-10 or corresponding International Classification of Primary Care 2nd edition [ICPC-2] codes) will be considered 6 - Number of major acute cardiovascular events (MACE) First occurrence of the following MACE (using ICD-10 codes) will be considered: - Ischemic heart diseases - Non-fatal myocardial infarction - Fatal or non-fatal stroke based - Unstable angina 7 - Number of unscheduled cardiovascular or respiratory inpatient hospitalizations or hospital emergency room visits or primary care visits to physician For all occurrences of selected outcomes the following characterization will be described: - Onset of event - Duration of event 8 - Number of participants reporting listed serious adverse events (SAEs) Number of serious adverse reactions (SARs), adverse event of special interest (AESI)s, and all fatal cases occuring throughout the study wi	—

Measure

Time frame

Secondary end point(s): 1 - Number of inpatient hospitalizations with primary discharge diagnosis Inpatient hospitalization with primary discharge diagnosis (using ICD-10 codes) for the following diseases will be considered: - Diseases of the respiratory system - Diseases of the circulatory system - Pneumonia - Heart failure - Acute myocardial infarction - Atrial Fibrillation - Stroke - Influenza and pneumonia 2 - Number of deaths Death all-cause and based on the diseases listed in first secondary endpoint will be considered 3 - Number of inpatient hospitalizations with primary and secondary admission and discharge diagnoses Inpatient hospitalization with primary discharge and second admission discharge diagnosis based on the diseases listed in first secondary endpoint will be considered 4 - Number of hospital emergency room visits Hospital emergency room visits based on the diseases listed in first secondary endpoint will be considered 5 - Number of acute primary care visits to physician Acute primary care visits to physician based on the diseases listed in first secondary endpoint (using ICD-10 or corresponding International Classification of Primary Care 2nd edition [ICPC-2] codes) will be considered 6 - Number of major acute cardiovascular events (MACE) First occurrence of the following MACE (using ICD-10 codes) will be considered: - Ischemic heart diseases - Non-fatal myocardial infarction - Fatal or non-fatal stroke based - Unstable angina 7 - Number of unscheduled cardiovascular or respiratory inpatient hospitalizations or hospital emergency room visits or primary care visits to physician For all occurrences of selected outcomes the following characterization will be described: - Onset of event - Duration of event 8 - Number of participants reporting listed serious adverse events (SAEs) Number of serious adverse reactions (SARs), adverse event of special interest (AESI)s, and all fatal cases occuring throughout the study wi

—

Countries

Finland

Contacts

Public ContactStéphanie Pepin

Sanofi Pasteur

Stephanie.Pepin@sanofi.com+33437 37 5850

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026