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EV71 Vaccine
Clinical Trial for Batch Consistency of EV71 Vaccine
Ensayo de SINOVAC BIOTECH LTD en EV71 Vaccine (del registro, en inglés).
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 720
- Centros
- 1
- Fin del objetivo primario
- abr 2020
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en sep 2019.
Qué mide
The GMT of EV71 neutralizing antibodies 30 days after complete immunization with the EV71 vaccine (30 days after second dose) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Subjects from different age groups are randomly allocated to three batch groups in a 1:1:1 ratio, and receive two doses of the EV71 vaccine from the commercial production batch on days 0 and 30. After each vaccination dose, subjects will be observed for immediate reactions for 30 minutes and for solicited adverse events for the next 7 days, as well as for unsolicited adverse events over the 30 days following vaccination. All subjects will have blood samples collected on day 0 (pre-immunization) and day 60 for serum antibody testing. Additionally, 270 subjects will be selected, for additional blood sampling at various time points: 7 days, 14 days, and 30 days after the first dose, and 7 days and 14 days after the second dose, to assess the EV71 antibody levels at different timepoints following various doses of vaccination.
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Todos los de SVA, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07026500), actualizada en jun 2025.