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

NCT03865238 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3061

Last updated 2022-04-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Principal Investigators

  • Li-Min Huang, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2021-04-16
Completion
2021-04-16

Countries

  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865238 on ClinicalTrials.gov