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Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
Ensayo de Sanofi en Infeccion por virus respiratorio sincitial.
Más ensayos de: Infección por virus respiratorio sincitial.
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 344
- Centros
- 15
- Fin del objetivo primario
- jul 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en jul 2023.
Qué mide
RSV A serum neutralizing antibody (Nab) titers (del registro, en inglés) (en el dia 1)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to \< 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05964582), actualizada en sep 2024.