Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older
Summary
Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations. Secondary Objective: * To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of: * inpatient hospitalization for selected circulatory and respiratory causes * death, either all-cause or cardiovascular or respiratory causes * inpatient hospitalization (using primary and secondary discharge diagnoses) * inpatient hospitalization (using admission diagnoses) * hospital emergency room visits * primary care visits to physician or * major acute cardiovascular events (MACE) * To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups. * To describe the clinical relative effectiveness of QIV-HD as compared to QIV-SD: * by age group and by group with specific comorbidities * for different periods of observation * To describe all serious adverse events (SAEs) (including adverse event of special interest \[AESIs\]) for all subjects in both QIV-HD and QIV-SD groups.
Timeline
- Start
- 2019-11-04
- Primary completion
- 2020-05-31
- Completion
- 2020-05-31
Publications
- Palmu AA, Pepin S, Syrjanen RK, Mari K, Mallett Moore T, Jokinen J, Nieminen H, Kilpi T, Samson SI, De Bruijn I. High-Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults. Influenza Other Respir Viruses. 2024 Apr;18(4):e13270. doi: 10.1111/irv.13270.
- Hollingsworth R, Palmu A, Pepin S, Dupuy M, Shrestha A, Jokinen J, Syrjanen R, Nealon J, Samson S, De Bruijn I. Effectiveness of the quadrivalent high-dose influenza vaccine for prevention of cardiovascular and respiratory events in people aged 65 years and above: Rationale and design of a real-world pragmatic randomized clinical trial. Am Heart J. 2021 Jul;237:54-61. doi: 10.1016/j.ahj.2021.03.007. Epub 2021 Mar 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efluelda | Vaccine | 0.7 ml | Intramuscular |
| Comparator | NITRAMINE | Vaccine | 0.5 ml | Intramuscular |
Indications
No indication recorded.