A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
132
Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
All adverse events were records. Blood cell and biochemistry were performed.
Time frame: 6 months
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
virus neutralization assays were performed.
Time frame: 6 months
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Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm