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.
- Conditions
- Healthy volunteers (influenza vaccination)Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-004573-32-FR
- Lead Sponsor
- Centre Hospitalier Annecy Genevois
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 59
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Non-inclusion:
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.Patients subject to legal protection measures.
Exclusion:
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
These subjects will not be randomized and not followed after the second visit. Study team will propose influenza vaccination outside of the study, as per standard of care.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method