The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV
Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV
Pizhou County Center for Disease Control and Prevention
Pizhou, Jiangsu, China
The seroconversion rates (SCRs) of each group after primary immunization.
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. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
Time frame: 90 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 incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
SAEs during the period of safety monitoring will be collected.
Time frame: 90-420 days.
The post-immune antibody positive rate of each group after primary immunization.
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
Time frame: 90 days
The post-immune geometric mean titer (GMT) of each group after primary immunization.
GMT of each group after primary immunization which lasts 60 days.
Time frame: 90 days.
The geometric mean fold increase (GMI) of each group after primary immunization.
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The GMI is the increase of post-immune GMT from pre-immune GMT.
Time frame: 90 days
The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
Percentage of subjects with antibody ≥ 1:64 of each group after three-dose
Time frame: 90 days
The antibody positive rate of each group before booster dose.
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months.
Time frame: 420 days
The geometric mean titer (GMT) of each group before booster dose.
GMT of each group before booster dose which occurred at the age of 18months.
Time frame: 420 days.
The geometric mean fold increase (GMI) of each group before booster dose.
The GMI is the increase of post-immune GMT from pre-i mmune GMT.
Time frame: 420 days
The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months.
Time frame: 420 days
The post-immune antibody positive rate of each group after booster dose.
Subjects whose post-immune antibody level ≥ 1:8 are co nsidered antibody positive
Time frame: 570 days
The post-immune geometric mean titer (GMT) of each group after booster dose.
GMT of each group after booster dose. The booster dose at the age of 18months
Time frame: 570 days
The geometric mean fold increase (GMI) of each group after booster dose.
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time frame: 570 days
The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months.
Time frame: 570 days