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The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group 1 | Experimental | Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) |
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| Test group 2 | Experimental | Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) |
|
| Test group 3 | Experimental | High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) |
|
| Comparator | Active Comparator | Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Poliomyelitis Vaccine (Sabin strain) | Biological | Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage1: Seroconversion rate(%) | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay | 4 weeks after 3rd vaccination |
| Stage2: Seroconversion rate(%) | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay | 4 weeks after 3rd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Stage1: Seroconversion rate (%) | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay | 4 weeks after 2nd vaccination |
| Stage2: Seroprotection rate (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Tropical Medicine | Alabang | Philippines | ||||
| Mahidol University Faculty of Medicine Siriraj Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33351072 | Derived | Capeding MR, Gomez-Go GD, Oberdorfer P, Borja-Tabora C, Bravo L, Carlos J, Tangsathapornpong A, Uppala R, Laoprasopwattana K, Yang Y, Han S, Wittawatmongkol O. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study. J Infect Dis. 2022 Aug 24;226(2):308-318. doi: 10.1093/infdis/jiaa770. |
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| Inactivated Poliomyelitis Vaccine (Salk strain) | Biological | Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age. |
|
Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay
| 4 weeks after 3rd vaccination |
| Stage1: GMTs (Geometric Mean Titers) | Comparison of GMTs and GMT ratios | 4 weeks after 2nd and 3rd vaccination |
| Stage2: GMTs (Geometric Mean Titers) | Comparison of GMTs and GMT ratios | 4 weeks after 3rd vaccination |
| Bangkok |
| Thailand |
| Chiang Mai University Maharaj Nakhon Chiang Mai Hospital | Chiang Mai | Thailand |
| 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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