This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60\~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
The seroconversion rates (SCRs) of each group 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 post-immune geometric mean titer (GMT) of each group 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 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 solicited adverse events (AEs) of each group
Solicited AEs occurred within 7 days after each injection will be collected.
Time frame: 7 days
The incidences of unsolicited adverse events (AEs) of each group
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
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