A Clinical Study for Inactivated Vaccine Against EV71 (EV71)

August 15, 2017 updated by: Medigen Vaccine Biologics Corp.
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Mackay Memorial Hospital
      • Taipei, Taiwan
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan
        • National Taiwan University Hosptial
      • Taipei, Taiwan
        • Chang-Guang Memorial Hospital Lin-Kou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  1. Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
  2. The subjects' guardians are able to understand and sign the informed consent

Main Exclusion Criteria:

  1. Subject with previous known exposure to EV71.
  2. Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
  3. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
  4. Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
  5. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
  6. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Phosphate Buffer Saline with adjuvant aluminium phosphate
Biological: Placebo
Phosphate Buffer Saline with adjuvant aluminium phosphate
Experimental: EV71 with adjuvant aluminium phosphate
Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml
Biological: EV71 with adjuvant aluminium phosphate
Two arms, EV71 with aluminium phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate overall safety of EV71 vaccine in children, throughout the study period
Time Frame: 2 years after study initiation
Occurrence of overall adverse events and serious adverse events during the entire period of study.
2 years after study initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
Time Frame: 2 years from study initiation

To evaluate the immunogencity in terms of

  • Geometric mean titer (GMT) of EV71 neutralizing antibody titers
  • Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers
  • Seropositivity rate
2 years from study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medigen Vaccine Biologics Corp.

Investigators

  • Principal Investigator: Li-Min Huang, M.D., PhD., National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-EV-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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