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Quadrivalent Influenza Vaccine
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
Ensayo de Sanofi en Influenza (Healthy Volunteers) (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 33.096
- Centros
- 1
- Fin del objetivo primario
- may 2020
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en nov 2019.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Enrollment terminated due to the COVID-19 pandemic».
Qué mide
Number of Participants With Hospitalizations Due to Cardiovascular or Respiratory Diseases (From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary 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.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04137887), actualizada en sep 2025.