This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to \<12yrs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
366
Two arms, EV71 with aluminium phosphate
Phosphate Buffer Saline with adjuvant aluminium phosphate
Chang-Guang Memorial Hospital Lin-Kou
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hosptial
Taipei, Taiwan
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.
Time frame: 2 years after study initiation
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
Time frame: 2 years from study initiation
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