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

An Open-label, Dose-finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Enimmune Corporation · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Enterovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)	Two vaccinations at 28 days apart
BIOLOGICAL	EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)	Two vaccinations at 28 days apart
BIOLOGICAL	EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)	Two vaccinations at 28 days apart
BIOLOGICAL	EV71 vaccine (2 μg total protein per dose)	Two vaccinations at 28 days apart
BIOLOGICAL	EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)	Two vaccinations at 28 days apart
BIOLOGICAL	EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)	Two vaccinations at 28 days apart
BIOLOGICAL	EV71 vaccine (1 μg total protein per dose)	Two vaccinations at 28 days apart

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2016-05-19
• Last updated: 2016-11-30

Locations

4 sites across 1 country: Taiwan