A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

3,982

Participants

Timeline

Start Date

June 27, 2018

Primary Completion Date

August 30, 2024

Study Completion Date

December 31, 2024

Conditions
Enterovirus Infections
Interventions
BIOLOGICAL

EV71 vaccine

EV71 vaccine (\[1 μg total protein + adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

BIOLOGICAL

Placebo

Placebo (\[ adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Trial Locations (8)

Unknown

Changhua Christian Hospital, Changhua

National Taiwan University Hospital HsinChu Branch, Hsinchu

China Medical University Hospital, Taichung

Taichung Veterans General Hospital, Taichung

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Linkou Chang Gung Memorial Hospital, Taoyuan District

Pasteur Institute of HCMC, Ho Chi Minh City

Sponsors
All Listed Sponsors
lead

Enimmune Corporation

INDUSTRY