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 | Completed Phase 4

• 1 other identifier: 21-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change of Transcriptomic profiles

  Transcriptomic profiles of blood cells (microarrays) will be performed to measure early systemic innate immune response

  Change from Baseline Transcriptomic profiles at day after vaccine injection (Day 1)

• Change of Innate cellular phenotyping

  Innate cellular phenotyping will be performed using 36 surface markers deciphering lineage cells monocytes, neutrophils, NK, antigen-presenting cells.

  Change from Baseline Innate cellular phenotyping at day after vaccine injection (Day 1)

• Change of Gene signature

  Study of the transcriptional profile of the blood cells by microarrays

  Change from Baseline Gene signature at day after vaccine injection (Day 1)

• Humoral immune responses

  HAI titers, Individual HAI titers ratio, Subjects with titers ≥ 40, Seroconversion

  Day 0, Day 21, Day 90 and Day 210 time

Study Arms (2)

High-Dose Quadrivalent Influenza Vaccine

EXPERIMENTAL

One injection of the high-dose Efluelda vaccine will be given to the patient

Biological: Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda)

Standard-Dose Quadrivalent Influenza Vaccine

ACTIVE COMPARATOR

One injection of the standard-dose Influvactetra vaccine will be given to the patient

Biological: Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine

Interventions

Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda) BIOLOGICAL

Patient will received one dose of High Dose Quadrivalent Influenza Vaccine according to marketing authorization.

High-Dose Quadrivalent Influenza Vaccine

Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine BIOLOGICAL

Patient will received one dose of Standard Dose Quadrivalent Influenza Vaccine according to marketing authorization.

Standard-Dose Quadrivalent Influenza Vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Have signed and dated Informed Consent Form;
• Able and willing to attend all scheduled visits, and to comply with study procedures;
• Covered by French health insurance.
• Already vaccinated against influenza for 2021-2022 season;
• 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;
• HIV infection;
• Active Hepatitis B, or active Hepatitis C;
• Previous Guillain Barré syndrome;
• Ongoing immunosuppressive treatment or active immunodeficiency;
• Receipt of immune globulins, blood or blood-derived products in the past 3 months;
• Thrombocytopenia or bleeding disorder, receipt of anticoagulants contraindicating IM vaccination based on investigator's judgment;
• Personnes referred to in articles L1121-6 and L1121-8 of Public Health Code (persons deprived of liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or curatorship).

You may not qualify if:

• Subject unable to attempt visit at Day 0 (visit 2) and Day 1 (visit 3);
• Blood sample at Day 0 (visit 2) impossible to obtain;
• Any unexpected event relevant to the physician in charge, after discussion with the coordinating investigator and the sponsor

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• Sanofi Pasteur, a Sanofi Company: collaborator
• Euraxi Pharma: collaborator
• Hospices Civils de Lyon: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Eurofins Optimed: collaborator

Study Sites (2)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

Location

Centre Hospitalier Métropole Savoie

Chambéry, France

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Cecile JANSSEN

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 13, 2021
• Study Start: November 15, 2021
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: August 8, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)