A Clinical Study for Inactivated Vaccine Against EV71 | NCT02200237 | Trialant
CompletedInterventionalPhase 2Updated Aug 18, 2017
A Clinical Study for Inactivated Vaccine Against EV71
ClinicalTrials.gov ID
NCT02200237
Lead Sponsor
Medigen Vaccine Biologics Corp.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
366Actual
Last Update Posted
Aug 18, 2017Actual
Start Date
Sep 2014
Primary Completion Date
May 2017Actual
Completion Date
Aug 2017Actual
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.
Enterovirus 71 Human
EV71 with adjuvant aluminium phosphate
Placebo
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.