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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Influenza (Healthy Volunteers)
Interventions: Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD), Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)
Countries: Finland
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.
Sex: ALL
Age: 65 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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.- Tampere, Finland