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To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | sIPV: Sinovac Biotech Co., Ltd., Beijing |
|
| control group | Active Comparator | sIPV: Beijing Institute of Biological Products Co., LTD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV | Biological | One dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Increase (GMI) | -The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination; | 30 days |
| Geometric Mean Titer (GMT) | -The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination; | 30 days |
| Seropositivity rate | -The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination; | 30 days |
| Seroconversion rate | -The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination; | 30 days |
| Adverse reaction incidence | -The incidence of adverse reaction within 30 days after vaccination; | 30 days |
| Serious adverse events incidence | -The incidence of serious adverse events within 30 days after vaccination. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Wang | Hubei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disease Control and Prevention Center, Xiaonan District, Xiaogan City | Xiaogan | 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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| 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 |