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Quadrivalent influenza vaccine · QHD00014
Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 100
- Centros
- 10
- Fin del objetivo primario
- jun 2021
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2020.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was interrupted due to COVID-19 pandemic and terminated due to new changes to the recommendations for flu vaccines».
Qué mide
Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes (From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type. The secondary objectives of the study were: * To compare QIV-HD to QIV-SD: * in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type using a more stringent threshold * in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine. * in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types. * To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age * To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response * To describe the immune response to revaccination in Season 3 (Northern Hemisphere) * To describe the safety profile of each vaccine
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04544267), actualizada en dic 2025.