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JE-CV Vaccine

Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

Ensayo de Sanofi en Japanese Encephalitis · Varicella (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

454

previstos

Centros

1

Fin del objetivo primario

oct 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2010.

Qué mide

Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV (Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine. Objectives: * To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine * To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects. * To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination. * To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01190228), actualizada en mar 2022.