A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01268787
First received: December 30, 2010
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01268787

Contacts
Contact: Mei Hu, B.S +886-37-246166 ext 37958 meihua@nhri.org.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Shihlin District, Taiwan, 112
Contact: C P Fung, MD    +886-2-28712121    cpfung@vghtpe.gov.tw   
Principal Investigator: C P Fung, M.D         
National Taiwan University Hospital Recruiting
Taipei, Zhongshan Distric, Taiwan, 104
Contact: S M Hsieh, M.D.    886-2-23123456    hsmaids@hotmail.com   
Principal Investigator: S M Hsieh, M.D.         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
Study Chair: Pele Chone, Ph.D. National Health Research Institutes, Taiwan
Study Director: Chia 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

No publications provided by National Health Research Institutes, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaccine Research and Developmental Center, Tawian, National Health Research Institutes, Tawian
ClinicalTrials.gov Identifier: NCT01268787     History of Changes
Other Study ID Numbers: QCR-10013
Study First Received: December 30, 2010
Last Updated: August 8, 2011
Health Authority: Taiwan : Food and Drug Administration
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 20, 2014