A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

August 31, 2017

Study Completion Date

December 31, 2017

Conditions
Enterovirus Infections
Interventions
BIOLOGICAL

EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

Two vaccinations at 28 days apart

BIOLOGICAL

EV71 vaccine ([1 μg total protein ] per dose)

Two vaccinations at 28 days apart

Trial Locations (4)

Unknown

China Medical University Hospital, Taichung

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Linkou Chang Gung Memorial Hospital, Taoyuan District

Sponsors
All Listed Sponsors
lead

Enimmune Corporation

INDUSTRY