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Clinical Trials List

Protocol NumberEV-BR1701
NCT Number(ClinicalTrials.gov Identfier)NCT05099029
Completed

2018-06-01 - 2024-12-31

Phase III

Terminated7

ICD-10B34.1

Enterovirus infection, unspecified

ICD-9047.0

Meningitis due to coxsackie virus

A Phase III, Multiple-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children

  • Trial Applicant

    ENIMMUNE CORPORATION

  • Sponsor

    ENIMMUNE CORPORATION

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/15

Investigators and Locations

Principal Investigator Kao-Pin Hwang Division of Pediatrics
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Li-Min Huang Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator Chou-Cheng Lai Division of Pediatrics
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator PO - YEN CHEN Division of Pediatrics
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 楊順成 Division of Pediatrics
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 陳文發 Division of Pediatrics
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Kao-Pin Hwang 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Yhu-Chering Huang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Enterovirus Infections

Objectives

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Test Drug

"安拓伏"腸病毒71型疫苗

Active Ingredient

安拓伏"腸病毒71型疫苗

Dosage Form

Pre-filled injection

Dosage

1 μg viral protein with 150 μg Al (OH)3

Endpoints

The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination. Evaluate the efficacy of EV71 vacccine against HFMD caused by EV71 From 28 days after the second vaccination to two year
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine Evaluate the immunogenicity by the response rate 28 days after the second vaccination

Inclution Criteria

Healthy children aged from 2 months to 6 years old (i.e. >= 2 months old and < 7 years old) at the time of first vaccination.
Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
Subject is able and can comply with the requirements of the protocol.
Subject with body temperature <= 38℃.

Exclusion Criteria

Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.
Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.
Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Subject under 2 years old with gestation <34weeks or a birth weight <2200g.
History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.
Severe malnutrition or dysgenopathy at the screening visit.
Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.
Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affect subject participation in the study in the opinion of the investigator.
Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
Any acute febrile illness 3 days prior to administrating the first vaccination.
Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during Visit 1 to Visit 4 (Day 0 to Day 196).
Administration of any vaccine within 14 days prior to each study vaccination.
Use of immunoglobulins or any blood products within 3 months prior to vaccination.
Chronic administration (defined as > 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination.
Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
Subject with any confirmed or suspected immunodeficiency.

The Estimated Number of Participants

  • Taiwan

    1256 participants

  • Global

    3982 participants

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