Back to resultsA Clinical Study for Inactivated Vaccine Against EV71 (EV71)
Primary Purpose
Enterovirus 71 Human
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
EV71 with adjuvant aluminium phosphate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Enterovirus 71 Human focused on measuring EV71 Vaccine
Eligibility Criteria
Main Inclusion Criteria:
- Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
Main Exclusion Criteria:
- Subject with previous known exposure to EV71.
- Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
- 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.
- Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
- Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Sites / Locations
- Chang-Guang Memorial Hospital Lin-Kou
- Far Eastern Memorial Hospital
- MacKay Memorial Hospital
- National Taiwan University Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
EV71 with adjuvant aluminium phosphate
Arm Description
Phosphate Buffer Saline with adjuvant aluminium phosphate
Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml
Outcomes
Primary Outcome Measures
To evaluate overall safety of EV71 vaccine in children, throughout the study period
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
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
Full Information
NCT ID
NCT02200237
First Posted
July 18, 2014
Last Updated
August 15, 2017
Sponsor
Medigen Vaccine Biologics Corp.
1. Study Identification
Unique Protocol Identification Number
NCT02200237
Brief Title
A Clinical Study for Inactivated Vaccine Against EV71
Acronym
EV71
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medigen Vaccine Biologics Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterovirus 71 Human
Keywords
EV71 Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Phosphate Buffer Saline with adjuvant aluminium phosphate
Arm Title
EV71 with adjuvant aluminium phosphate
Arm Type
Experimental
Arm Description
Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml
Intervention Type
Biological
Intervention Name(s)
EV71 with adjuvant aluminium phosphate
Intervention Description
Two arms, EV71 with aluminium phosphate
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Phosphate Buffer Saline with adjuvant aluminium phosphate
Primary Outcome Measure Information:
Title
To evaluate overall safety of EV71 vaccine in children, throughout the study period
Description
Occurrence of overall adverse events and serious adverse events during the entire period of study.
Time Frame
2 years after study initiation
Secondary Outcome Measure Information:
Title
To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
Description
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
Time Frame
2 years from study initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Main Inclusion Criteria:
Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
The subjects' guardians are able to understand and sign the informed consent
Main Exclusion Criteria:
Subject with previous known exposure to EV71.
Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
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.
Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Min Huang, M.D., PhD.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang-Guang Memorial Hospital Lin-Kou
City
Taipei
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hosptial
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study for Inactivated Vaccine Against EV71
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