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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

NCT05154383 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-08

No results posted yet for this study

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.

Conditions

  • Vaccine Reaction

Interventions

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.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Euraxi Pharma

    collaborator INDUSTRY

  • Hospices Civils de Lyon

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Eurofins Optimed

    collaborator INDUSTRY

  • Centre Hospitalier Annecy Genevois

    lead OTHER

Principal Investigators

  • Cecile JANSSEN · CH Annecy Genevois

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-07-21
Completion
2022-07-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154383 on ClinicalTrials.gov