Enterovirus 71 Human
Conditions
Keywords
EV71 Vaccine
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.
Interventions
BIOLOGICALEV71 with adjuvant aluminium phosphate
Two arms, EV71 with aluminium phosphate
BIOLOGICALPlacebo
Phosphate Buffer Saline with adjuvant aluminium phosphate
Sponsors
Medigen Vaccine Biologics Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate overall safety of EV71 vaccine in children, throughout the study period | 2 years after study initiation | Occurrence of overall adverse events and serious adverse events during the entire period of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine | 2 years from study initiation | 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 |
Countries
Taiwan
Outcome results
None listed