The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.
This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,300
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Yanshan County Center for Disease Control and Prevention
Wenshan, Yunnan, China
Qiubei County Center for Disease Control and Prevention
Wenshan, Yunnan, China
Mile City Center for Disease Control and Prevention
Yisa, Yunnan, China
Gejiu County Center for Disease Control and Prevention
Yisa, Yunnan, China
Immunogenicity index-Geometric mean titer of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay
Time frame: The 30th day after the third dose vaccination
Immunogenicity index-Seroconversion rates of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (\<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.
Time frame: The 30th day after the third dose vaccination
Immunogenicity index-Seropositive rate of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8.
Time frame: The 30th day after the third dose vaccination
Immunogenicity index-Geometric mean ratio of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Geometric mean ratio of neutralizing antibody titer after vaccination divided by that before vaccination
Time frame: The 30th day after the third dose vaccination
Safety index-Incidence of solicited adverse events
Solicited adverse events refer to the adverse events occur within day 0-7 after each dose vaccination with the solicited symptoms including injection-site induration, redness, swelling, rashes, or pruritus, and fever, allergic reactions, abnormal activity level, loss of appetite, nausea, vomiting and diarrhea.
Time frame: Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
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Three doses control wIPV at the schedule of 2,3,4 months of age
Safety index-Incidence of unsolicited adverse events
Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period
Time frame: Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of serious adverse events (SAEs)
SAEs refers to the events occur in the process of clinical trial which may need hospitalization, prolongation of hospitalization time, disability, dysfunction, be life-threatening or death or lead to congenital malformation.
Time frame: From the beginning of vaccination to 30 days after the third dose vaccination