NCT03865238

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine

A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled, Multi-region Study to Evaluate the Efficacy, Safety, and Immunogenicity of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant in Infants and Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,061 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 2 Months – 6 Years
• Healthy volunteers: Accepted

Summary

Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to \< 2 years of age. The last study visit is on Day 422 when subjects will be contacted via telephone / home visit system to assess for adverse events and concomitant medications.

Conditions

• Enterovirus 71 Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-23
• Primary completion: 2021-04-16
• Completion: 2021-04-16
• First posted: 2019-03-06
• Last updated: 2022-04-19

Locations

6 sites across 2 countries: Taiwan, Vietnam