The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
140
Two vaccinations at 28 days apart
Two vaccinations at 28 days apart
Two vaccinations at 28 days apart
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56
Time frame: Day 56
Seroconversion rate (SCR) based on neutralizing antibody titers
Evaluate the immunogenicity change of SCR from baseline on Day 56
Time frame: Day 56
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28
Time frame: Day 28
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196
Time frame: Day 196
Seroconversion rate (SCR) based on neutralizing antibody titers
Evaluate the immunogenicity change of SCR from baseline on Day 28
Time frame: Day 28
Seroconversion rate (SCR) based on neutralizing antibody titers
Evaluate the immunogenicity change of SCR from baseline on Day 196
Time frame: Day 196
Solicited adverse events
Time frame: 7 days after each vaccination
Unsolicited adverse events
Time frame: 28 days after each vaccination
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The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
Time frame: Day 0 to Day 196
The occurrence of EV 71 breakthrough infection after Visit 3
Time frame: Day 57 to Day 364
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364
Time frame: Day 364