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The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '1+2' sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants
This 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 Vaccine Technology Co., Ltd in a '1+2' 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-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | sIPV-bOPV-bOPV vaccination schedule |
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| Control Group | Active Comparator | wIPV-bOPV-bOPV vaccination schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV-bOPV-bOPV vaccination schedule | Biological | Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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/wIPV) or 14 days(for bOPV) after each injection will be collected. | 7 days or 14 days |
| The incidence of unsolicited AE within 30 days after each dose of each group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guanyun Center for Disease Control and Prevention | Lianyungang | Jiangsu | 222200 | China |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| wIPV-bOPV-bOPV vaccination schedule | Biological | Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd. |
|
Unsolicited AEs occurred within 30 days after each injection will be collected. |
| 30 days |
| Incidence of serious adverse events (SAEs) during the period of safety monitoring. | SAEs during the period of safety monitoring will be collected. | 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). | 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 | 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. | 30 days |
| 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 |