To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
One dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD.
Disease Control and Prevention Center, Xiaonan District, Xiaogan City
Xiaogan, China
Geometric Mean Increase (GMI)
-The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Geometric Mean Titer (GMT)
-The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Seropositivity rate
-The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Seroconversion rate
-The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Adverse reaction incidence
-The incidence of adverse reaction within 30 days after vaccination;
Time frame: 30 days
Serious adverse events incidence
-The incidence of serious adverse events within 30 days after vaccination.
Time frame: 30 days
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