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

QHD00012

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.

2019-11-04

2020-05-31

2020-05-31

Terminated

Early phase I

33096

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.

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2023-06-08