Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial. This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis,RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
72
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
0/0.5ml placebo, two doses, 4 weeks interval
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years
Time frame: Frame: 3 days after first dose
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years
Time frame: 7 days after first dose
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years
Time frame: 28 days after first dose
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years
Time frame: 28 days after second dose
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years
Time frame: 6 months after first dose
GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination
GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
Time frame: 28 days after the first vaccination
GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination
GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
Time frame: 28 days after second vaccination
the safety of EV71 vaccine in healthy children aged 2-5 years
Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years
Time frame: 28 days after the first dose
the safety of EV71 vaccine in healthy children aged 2-5 years
Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years
Time frame: 28 days after the second dose
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