NCT03865238 - A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine | Biotech Hunter

Enrollment

3,061

Participants

Timeline

Start Date

April 23, 2019

Primary Completion Date

April 16, 2021

Study Completion Date

April 16, 2021

Conditions

Enterovirus 71 Infection

Interventions

BIOLOGICAL

EV71vac

Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to \< 2 years of age will receive a booster vaccination on Day 366.

BIOLOGICAL

Placebo

Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to \< 2 years of age will receive a booster vaccination on Day 366.

Trial Locations (6)

Unknown

Mackay Memorial Hospital, HsincChu, Hsinchu

Taichung Veteran General Hospital, Taichung

Mackay Memorial Hospital, Taipei, Taipei

National Taiwan Univeristy Hospital, Taipei

Chang Gung Memorial Hospital, LinKou, Taoyuan District

Pasteur Institute of HCMC, Ho Chi Minh City