Back to results

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

Primary Purpose

Enterovirus 71 Infection

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

EV71vac

Placebo

About this trial

This is an interventional prevention trial for Enterovirus 71 Infection

Eligibility Criteria

2 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.
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).
Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
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).
Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.

Sites / Locations

Mackay Memorial Hospital, HsincChu
Taichung Veteran General Hospital
Mackay Memorial Hospital, Taipei
National Taiwan Univeristy Hospital
Chang Gung Memorial Hospital, LinKou
Pasteur Institute of HCMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EV71vac

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03865238

First Posted

February 20, 2019

Last Updated

April 18, 2022

Sponsor

Medigen Vaccine Biologics Corp.

1. Study Identification

Unique Protocol Identification Number

NCT03865238

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 23, 2019 (Actual)

Primary Completion Date

April 16, 2021 (Actual)

Study Completion Date

April 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medigen Vaccine Biologics Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enterovirus 71 Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3061 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EV71vac

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

EV71vac

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Laboratory Confirmed EV71-Associated Disease

Description

The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay.

Time Frame

Approximately 14 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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. 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). Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period. 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). Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li-Min Huang, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mackay Memorial Hospital, HsincChu

City

Hsinchu

Country

Taiwan

Facility Name

Taichung Veteran General Hospital

City

Taichung

Country

Taiwan

Facility Name

Mackay Memorial Hospital, Taipei

City

Taipei

Country

Taiwan

Facility Name

National Taiwan Univeristy Hospital

City

Taipei

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital, LinKou

City

Taoyuan

Country

Taiwan

Facility Name

Pasteur Institute of HCMC

City

Ho Chi Minh City

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

35427481

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs