The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18\~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18\~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety. The antigen contents of type I, type II and type III polioviruses in the high-dose Sabin IPV were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, China
The seroconversion rates (SCRs) of each group 30 days after three-dose regimen
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Time frame: 28~42 days
The geometric mean titer (GMT) of each group 30 days after three-dose regimen
GMT of each group 28\~42 days after three-dose regimen
Time frame: 28~42 days
The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT
Time frame: 28~42 days
The incidences of adverse reactions of each group occurred within 30 days after each injection
The number of participants who had adverse reactions divided by the number of all participants
Time frame: 30 days
The incidences of adverse events (AEs) of each group occurred within 30 days after each injection
The number of participants who had adverse events (AEs) divided by the number of all participants
Time frame: 30 days
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