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Trial record 2 of 30 for:    ev71

A Clinical Study for Inactivated Vaccine Against EV71 (EV71)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medigen Vaccinology Corp.
ClinicalTrials.gov Identifier:
NCT02200237
First received: July 18, 2014
Last updated: March 29, 2016
Last verified: March 2016
  Purpose
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.

Condition Intervention Phase
Enterovirus 71 Human
Biological: EV71 with adjuvant aluminium phosphate
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Medigen Vaccinology Corp.:

Primary Outcome Measures:
  • To evaluate overall safety of EV71 vaccine in children, throughout the study period [ Time Frame: 2 years after study initiation ] [ Designated as safety issue: Yes ]
    Occurrence of overall adverse events and serious adverse events during the entire period of study.


Secondary Outcome Measures:
  • To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine [ Time Frame: 2 years from study initiation ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 365
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Months to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT02200237

Locations
Taiwan
Chang-Guang Memorial Hospital Lin-Kou
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hosptial
Taipei, Taiwan
Sponsors and Collaborators
Medigen Vaccinology Corp.
Investigators
Principal Investigator: Li-Min Huang, M.D., PhD. National Taiwan University Hospital
  More Information

Responsible Party: Medigen Vaccinology Corp.
ClinicalTrials.gov Identifier: NCT02200237     History of Changes
Other Study ID Numbers: CT-EV-21 
Study First Received: July 18, 2014
Last Updated: March 29, 2016
Health Authority: Taiwan : Food and Drug Administration
Taiwan: Research Ethics Committee

Keywords provided by Medigen Vaccinology Corp.:
EV71 Vaccine

Additional relevant MeSH terms:
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Aluminum phosphate
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on December 07, 2016