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QHD04

Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

Ensayo de Sanofi en Gripe.

Más ensayos de: Gripe.

Fase

Fase 2

Estado

Completado

Participantes

665

previstos

Centros

16

Fin del objetivo primario

oct 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2018.

Qué mide

Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination (Within 30 minutes after any vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe objectives of this study were: * To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study). * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method. * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method. * To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03698279), actualizada en mar 2022.