Calendario›SNY›RSVt Vaccine · PEARL
RSVt Vaccine · PEARL
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Ensayo de Sanofi en RSV Immunisation (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 6.300
- Centros
- 130
- Fin del objetivo primario
- dic 2025
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en feb 2024.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision».
Qué mide
Occurrence of lower respiratory tract disease (LRTD) (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2 (from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo. Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06252285), actualizada en ene 2026.