A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

April 15, 2015 updated by: National Health Research Institutes, Taiwan

A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers

This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

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
    • Shihlin District
      • Taipei, Shihlin District, Taiwan, 112
        • Taipei Veterans General Hospital
    • Zhongshan Distric
      • Taipei, Zhongshan Distric, Taiwan, 104
        • National Taiwan University Hospital

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject who is free of obvious health problems
  • Able and willing to comply with the study procedure adn give written informed consent

Exclusion Criteria:

  • Female who is pregnant/lactating or planning to be pregnant
  • Body mass index(BMI) > 35
  • Oral temperature > 37.5 Celsius at the time of planned vaccination
  • Subject with any abnormal laboratory results at screening
  • With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
  • Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
  • With a history of hypersensitivity to vaccine or allergic disease
  • Use of any investigational/non-registered product within 30 days prior to vaccination
  • Use of immunoglobulins or any blood products within 3 months prior to vaccination
  • Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EV 71 vaccine 5ug
EV71 Vaccine 5ug
Biological: EV71 vaccine
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
Other Names:
  • EV71 vac
Experimental: EV 71 vaccine 10ug
EV71 vaccine 10ug
Biological: EV71 vaccine
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
Other Names:
  • EV71 vac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: 210 Days
The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose
210 Days

Collaborators and Investigators

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

Sponsor

National Health Research Institutes, Taiwan

Investigators

  • Study Chair: Pele Chong, Ph.D., National Health Research Institutes, Taiwan
  • Study Director: Chia-Chyi Liu, Ph.D., National Health Research Institutes, Taiwan
  • Principal Investigator: C P Fung, M.D., Taipei Veterans General Hospital, Taiwan
  • Principal Investigator: S M Hsieh, M.D, Taipei Meidcal College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 30, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QCR-10013

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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