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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Vaccine-lot 1 | Experimental | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
|
| Experimental Vaccine-lot 2 | Experimental | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
|
| Experimental Vaccine-lot 3 | Experimental | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
|
| Control Vaccine | Active Comparator | Wild strain IPV (wIPV)manufactured by Sanofi Pasteur S.A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age | Biological | Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-Geometric mean titer of neutralizing antibody | Micro-neutralization method will be used in the neutralizing antibody assay | 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. | The 30th day after the third dose vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The 30th day after the third dose vaccination |
| Immunogenicity index-Geometric mean ratio of neutralizing antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Zheng, Master | Yunnan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanshan County Center for Disease Control and Prevention | Wenshan | Yunnan | 663100 | China | ||
| Qiubei County Center for Disease Control and Prevention |
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| Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age | Biological | 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 | Biological | Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age |
|
| Three doses control wIPV at the schedule of 2,3,4 months of age | Biological | Three doses control wIPV at the schedule of 2,3,4 months of age |
|
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 |
| 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. | Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination |
| 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 | 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. | From the beginning of vaccination to 30 days after the third dose vaccination |
| Wenshan |
| Yunnan |
| 663200 |
| China |
| Mile City Center for Disease Control and Prevention | Yisa | Yunnan | 652399 | China |
| Gejiu County Center for Disease Control and Prevention | Yisa | Yunnan | 661000 | China |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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