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| ID | Type | Description | Link |
|---|---|---|---|
| 2011L01484 | 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 and phase 2 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 type 1, 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. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.
Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.
This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections. |
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| Cohort 2: | Experimental | Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Poliomyelitis Vaccine (Sabin strains) | Biological | Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart. |
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| Measure | Description | Time Frame |
|---|---|---|
| The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants | Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination. | fours year |
| Measure | Description | Time Frame |
|---|---|---|
| The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants | Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination | One year |
| Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for doses 2 and 3
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| Name | Affiliation | Role |
|---|---|---|
| Guoyang Liao, PH.D | Institute of Medical Biology, Chinese Academy of Medical Sciences | Principal Investigator |
| Yanping Li, MD | Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control | Principal Investigator |
| Changgui Li, 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 Prevention and Control | Guilin | Guangxi | 530400 | China | ||
| Bingyang Center for Disease Prevention and Control |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37745024 | Derived | Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct. |
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| Inactivated Poliomyelitis Vaccine (Salk strains) | Biological | Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart. |
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One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses. |
| 30-60 days after third dose immunization |
| Nanning |
| Guangxi |
| 530400 |
| 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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| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
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