Status:
COMPLETED
A Clinical Study for Inactivated Vaccine Against EV71
Lead Sponsor:
Medigen Vaccine Biologics Corp.
Conditions:
Enterovirus 71 Human
Eligibility:
All Genders
2-12 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT02200237
Start Date
September 1 2014
End Date
August 1 2017
Last Update
August 18 2017
Active Locations (4)
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1
Chang-Guang Memorial Hospital Lin-Kou
Taipei, Taiwan
2
Far Eastern Memorial Hospital
Taipei, Taiwan
3
MacKay Memorial Hospital
Taipei, Taiwan
4
National Taiwan University Hosptial
Taipei, Taiwan