The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants
his study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
Pizhou Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
The difference between experimental group and control group of type I,III neutralizing antibody seroconversion rate after primary immunization. And the lower limit of 95% confidence intervals of the difference value.
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: 30 days
The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.
Solicited AEs occurred within 7 days (for sIPV) or 14 days (for bOPV) after each injection will be collected.
Time frame: 7 days or 14 days
The incidence of unsolicited AE within 30 days after each dose of each group.
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
Incidence of serious adverse events (SAEs) during the period of safety monitoring.
SAEs during the period of safety monitoring will be collected.
Time frame: 30 days
Type I,II and III neutralizing 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: 30 days
Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.
GMT of each group after primary immunization
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Time frame: 30 days
Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization.
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time frame: 30 days
Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization.
Subjects whose post-immune antibody level ≥ 1:64 will be collected.
Time frame: 30 days