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A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

This study has been completed.
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan Identifier:
First received: December 30, 2010
Last updated: April 15, 2015
Last verified: October 2013
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

Condition Intervention Phase
Enterovirus Infection
Biological: EV71 vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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

Enrollment: 60
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: EV71 vac

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.

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01268787

Taipei Veterans General Hospital
Taipei, Shihlin District, Taiwan, 112
National Taiwan University Hospital
Taipei, Zhongshan Distric, Taiwan, 104
Sponsors and Collaborators
National Health Research Institutes, Taiwan
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Health Research Institutes, Taiwan Identifier: NCT01268787     History of Changes
Other Study ID Numbers: QCR-10013
Study First Received: December 30, 2010
Last Updated: April 15, 2015

Additional relevant MeSH terms:
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 27, 2017