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

Influenza (Healthy Volunteers) Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Influenza (Healthy Volunteers)
• Influenza, Human

• NCT number: NCT04137887
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 3
• Start date: November 4, 2019
• Completion date: May 31, 2020