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Live
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
Ensayo de Sanofi en Dengue · Dengue Hemorrhagic Fever · Yellow Fever (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 792
- Centros
- 2
- Fin del objetivo primario
- sep 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2011.
Qué mide
Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo (28 days Post-Injection 1) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration. Primary Objective: * To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to participants receiving one dose of Stamaril vaccine concomitantly with placebo. Secondary Objectives: * To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of participants at baseline. * To describe the YF immune response 28 days post-Stamaril vaccination in both groups. * To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD dengue vaccine (Visit \[V\] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2 from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect of YF vaccination). * To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo. * To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone. * To describe the safety of the CYD dengue vaccine in all participants after each dose.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01436396), actualizada en mar 2022.