NCT05154383

Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Annecy Genevois · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

Detailed description

The hypothesis is that higher dose of antigen can increase the intensity and the quality of innate immunity, as the adaptive humoral and cellular responses. In this study, the objectif is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older. Modifications of early blood molecular (transcriptome) and cellular (blood phenotyping) signatures within the first 24 hours following vaccination will be investigated. The association between early gene signature and late influenza-specific humoral immune responses weeks/months after vaccination will be also assessed. This study is a hase IV, randomized, open-label, active-controlled, multi-center study comparing the immune response induced by QIV-HD vaccine (intervention) and QIV-SD vaccine (control).

Conditions

• Vaccine Reaction

Interventions

Type	Name	Description
BIOLOGICAL	Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda)	Patient will received one dose of High Dose Quadrivalent Influenza Vaccine according to marketing authorization.
BIOLOGICAL	Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine	Patient will received one dose of Standard Dose Quadrivalent Influenza Vaccine according to marketing authorization.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2021-12-13
• Last updated: 2022-08-08

Locations

2 sites across 1 country: France