drugset / Trial / NCT02777411

A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

NCT02777411

Phase 2 Completed 122 enrolled Enimmune Corporation
RandomizedParallel-groupOpen-labelPrevention

Summary

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.

Timeline

Start
2014-12
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject AIPO4 Unknown 150 ug
Subject EV71 vaccine Vaccine 0.5 ug
Subject EV71 vaccine Vaccine 1 ug
Subject EV71 vaccine Vaccine 2 ug