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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

CompletedPhase 4

Sponsor: Centre Hospitalier Annecy Genevois

Conditions: Vaccine Reaction

Interventions: Experimental arm : High-Dose Quadrivalent Influenza Vaccine (Efluelda), Active Comparator: Standard-Dose Quadrivalent Influenza Vaccine

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Aged 65 years or older, the day of inclusion;
2. Have signed and dated Informed Consent Form;
3. Able and willing to attend all scheduled visits, and to comply with study procedures;
4. Covered by French health insurance.

Non-Inclusion Criteria :

1. Any vaccine injection (including COVID-19 vaccine) in the 4 weeks preceding study inclusion;
2. Plan to receive any vaccine (including COVID-19 vaccine) in the 4 weeks following study inclusion;
3. Already vaccinated against influenza for 2021-2022 season;
4. 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;
5. HIV infection;
6. Active Hepatitis B, or active Hepatitis C;
7. Previous Guillain Barré syndrome;
8. Ongoing immunosuppressive treatment or active immunodeficiency;
9. Receipt of immune globulins, blood or blood-derived products in the past 3 months;
10. Thrombocytopenia or bleeding disorder, receipt of anticoagulants contraindicating IM vaccination based on investigator's judgment;
11. Influenza-like illness symptoms, including COVID-19, within 4 weeks before study inclusion;
12. 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).

Exclusion Criteria:

1. Any subject presenting with influenza-like illness symptoms, including COVID-19 between inclusion (visit 1) and randomization (visit 2);
2. Subject unable to attempt visit at Day 0 (visit 2) and Day 1 (visit 3);
3. Blood sample at Day 0 (visit 2) impossible to obtain;
4. Receipt of vaccine injection or equivalent between inclusion (visit 1) and randomization (visit 2), other than those allowed and planned in the study. This includes non-study dose of 2021-2022 influenza vaccine, blood-derived immune globulins, blood, or blood-derived products.
5. Any unexpected event relevant to the physician in charge, after discussion with the coordinating investigator and the sponsor

Locations (2)

Annecy, France
Chambéry, France