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 AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
122
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
Solicited adverse events
Time frame: 7 days after each vaccination
Unsolicited adverse events
Time frame: 28 days after each vaccination
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
Time frame: Day 0 to Day 196
immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)
Time frame: Day 28, Day 56, Day 196
serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Time frame: Day 28, Day 56, Day 196
Seroconversion rate (SCR) based on neutralizing antibody titers
Time frame: Day 28, Day 56, Day 196
change in the laboratory results based on hematology tests in each visit
Time frame: Day 28, Day 56, Day 196
change in the laboratory results based on biochemistry tests in each visit
Time frame: Day 28, Day 56, Day 196
change in heart rates at each visit (for the 3 to 6 years old group only)
Time frame: Day 28, Day 56, Day 196
change in blood pressures at each visit (for the 3 to 6 years old group only)
Time frame: Day 28, Day 56, Day 196
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Two vaccinations at 28 days apart
Two vaccinations at 28 days apart
Two vaccinations at 28 days apart
Two vaccinations at 28 days apart