NCT04137887

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33,096 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD)	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular
BIOLOGICAL	Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2019-10-24
• Last updated: 2025-09-17
• Results posted: 2023-06-08

Locations

1 site across 1 country: Finland

Regulatory

• FDA-regulated drug study