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

Medigen Vaccine Biologics Corp.6 sites in 2 countries3,061 target enrollmentApril 23, 2019

ConditionsEnterovirus 71 Infection

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Enterovirus 71 Infection
Sponsor: Medigen Vaccine Biologics Corp.
Enrollment: 3061
Locations: 6
Primary Endpoint: Number of Laboratory Confirmed EV71-Associated Disease
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 23, 2019

End Date

April 16, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medigen Vaccine Biologics Corp.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy children and infants aged from 2 months to less than 6 years as established by medical history and clinical examination.
•The subjects' parents/guardians are able to understand and sign the ICF.

Exclusion Criteria

•Age \< 2 months or ≥ 6 years.
•For subjects \< 1 year, gestational age \< 34 weeks or birth weight \< 2200 grams.
•Has poor venous access (for subjects in sub-study only).
•Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
•Has had previous known exposure to EV71 or has received EV71 vaccine.
•Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the planned study drug vaccination.
•Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
•Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Has used any investigational/non-registered product (including drug, vaccine, or invasive medical device) within 28 days before vaccination or plan to use during the study period.
•Has confirmed or suspected autoimmune disorder, or immunodeficiency.