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

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.

Study Overview

• Status: Completed
• Conditions: Enterovirus 71 Infection
• Intervention / Treatment: Biological: EV71vac; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3061
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • Mackay Memorial Hospital, HsincChu
  • Taichung, Taiwan
    • Taichung Veteran General Hospital
  • Taipei, Taiwan
    • National Taiwan Univeristy Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital, Taipei
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital, Linkou
• Vietnam
  • Ho Chi Minh City, Vietnam
    • Pasteur Institute of HCMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Age < 2 months or ≥ 6 years.
2. For subjects < 1 year, gestational age < 34 weeks or birth weight < 2200 grams.
3. Has poor venous access (for subjects in sub-study only).
4. 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.
5. Has had previous known exposure to EV71 or has received EV71 vaccine.
6. 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.
7. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
8. 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.
9. 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.
10. Has confirmed or suspected autoimmune disorder, or immunodeficiency.
11. Administration of any licensed live attenuated vaccine within 14 days before or after each study vaccination (with the exceptions of live attenuated Rotavirus vaccine via oral route).
12. Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
13. Has had immunosuppressants, cytotoxic drugs, corticosteroids (including prednisolone ≥ 0.5 mg/kg/day or equivalent), or immunomodulators taken for > 14 days within 6 months before first vaccination or plan to use before the last scheduled study visit. (Inhaled and topical steroids are allowed).
14. Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: EV71vac	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Laboratory Confirmed EV71-Associated Disease	The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.	Approximately 14 months

Collaborators and Investigators

• Sponsor: Medigen Vaccine Biologics Corp.
• Investigators: Principal Investigator: Li-Min Huang, MD, National Taiwan University Hospital

Publications and helpful links

General Publications

• Nguyen TT, Chiu CH, Lin CY, Chiu NC, Chen PY, Le TTV, Le DN, Duong AH, Nguyen VL, Huynh TN, Truong HK, Phan TL, Nguyen TTT, Shih SR, Huang CG, Weng YJ, Hsieh EF, Chang S, Chen C, Tai IC, Huang LM. Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1708-1717. doi: 10.1016/S0140-6736(22)00313-0. Epub 2022 Apr 12.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Picornaviridae Infections; Enterovirus Infections
• Other Study ID Numbers: CT-EV-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No