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| ID | Type | Description | Link |
|---|---|---|---|
| SFDA2007L02021 | Other Identifier | China state food and drug adminstration |
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| Name | Class |
|---|---|
| Guangxi Center for Disease Control and Prevention | OTHER_GOV |
| National Institute for the Control of Pharmaceutical and Biological Products, China | OTHER |
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Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase â…¡ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.
Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.
This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Experiment Infants | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections; |
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| Cohort 2: Experiment infants | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections; |
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| Cohort 3: Experiment infants | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections; |
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| Cohort 4: Experiment infants | Experimental | Biological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral; |
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| Cohort 5: Experiment infants | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml intramuscular injections; |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Poliomyelitis Vaccine (Sabin strains) | Biological | Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants . | one year |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for doses 2 and 3
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| Name | Affiliation | Role |
|---|---|---|
| Liao Guoyang, PHD | Institute of Medical Biology, Chinese Academy of Medical Sciences | Principal Investigator |
| Li Rongcheng, MD | Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control | Principal Investigator |
| Li Changgui, PHD | National Institute for the Control of Pharmaceutical and Biological Products, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pingle Center for Disease Control and Prevention | Pingle County | Guangxi | 542400 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28419204 | Derived | Sun M, Li C, Xu W, Liao G, Li R, Zhou J, Li Y, Cai W, Yan D, Che Y, Ying Z, Wang J, Yang H, Ma Y, Ma L, Ji G, Shi L, Jiang S, Li Q. Immune Serum From Sabin Inactivated Poliovirus Vaccine Immunization Neutralizes Multiple Individual Wild and Vaccine-Derived Polioviruses. Clin Infect Dis. 2017 May 15;64(10):1317-1325. doi: 10.1093/cid/cix110. | |
| 22158682 |
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| Inactivated Poliomyelitis Vaccine (Sabin strains) | Biological | Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart. |
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| Inactivated Poliomyelitis Vaccine (Sabin strains) | Biological | Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart. |
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| Oral Poliomyelitis Vaccine | Biological | Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart. |
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| Inactivated Poliomyelitis Vaccine (Salk strains). | Biological | 3x0.5ml intramuscular injections, one month apart. |
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| Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8. |
| 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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| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
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