This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20,900
Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.
Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.
Time frame: 24 months
Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.
The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.
Time frame: 56 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.