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

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Enterovirus Infections
Interventions
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

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

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 | Biotech Hunter | Biotech Hunter