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RSV vaccine formulation 1 · VAD00001
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Ensayo de Sanofi en Respiratory Syncytial Virus Infection (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 259
- Centros
- 29
- Fin del objetivo primario
- abr 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2020.
Qué mide
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) (Cohorts 1 and 3: Within 30 minutes after vaccination on Day 0; Cohorts 2 and 4: Within 30 minutes after vaccination on Days 0 and 56) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objectives of the study were: * To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. * To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: * To quantify the amount of vaccine virus shed by each participant by baseline serostatus. * To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus. * To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants. * To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus. * To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04491877), actualizada en sep 2025.