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| Name | Class |
|---|---|
| Yunnan Center for Disease Control and Prevention | OTHER |
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A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.
This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.
A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Batch 1 of sIPV | Experimental | The first commercial batch of sIPV |
|
| Batch 2 of sIPV | Experimental | The second commercial batch of sIPV |
|
| Batch 3 of sIPV | Experimental | The third commercial batch of sIPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV batch 1 | Biological | Type I 30 DU, Type II 32 DU, Type III 45 DU |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of neutralizing antibody | Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed. | 1 month after primary immunization |
| Local and systemic adverse reactions | Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card. | Within 1 month after primary immunization |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of neutralizing antibody | Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody. Intergroup differences analysis of antibody level was conducted. | 1 month after primary immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoqiang Liu | Disease prevention and control center of Yunnan province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disease prevention and control center of Yunnan province | Kunming | Yunnan | 650022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38400200 | Derived | Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Quantitative Analysis of the Instant and Persistent Inhibition Effects of Maternal Poliovirus Antibodies on the Immune Response in a Phase IV Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine. Vaccines (Basel). 2024 Feb 19;12(2):217. doi: 10.3390/vaccines12020217. | |
| 38388236 |
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Participants do not agree to share the individual data.
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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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| sIPV batch 2 |
| Biological |
Type I 30 DU, Type II 32 DU, Type III 45 DU |
|
| sIPV batch 3 | Biological | Type I 30 DU, Type II 32 DU, Type III 45 DU |
|
| Derived |
| Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Immunogenicity and lot-to-lot consistency of booster shot with Sabin inactivated poliomyelitis vaccine in Chinese children aged 18-24 Months: A phase Ⅳ clinical trial. Vaccine. 2024 Mar 19;42(8):1973-1979. doi: 10.1016/j.vaccine.2024.02.042. Epub 2024 Feb 21. |
| 33487470 | Derived | Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22. |
| 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 |