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The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants |
|
| control group | Active Comparator | control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV+bOPV | Biological | 2+1 sequential" immunization program (sIPV-sIPV-bOPV) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody | Day 30 post full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of poliovirus type I, type II and type III neutralizing antibody | Day 30 post full vaccination | |
| GMI of poliovirus type I, type II and type III neutralizing antibody | Day 30 post full vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Center for Diseases Control and Prevention | Jinan | Shandong | 250014 | China |
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| wIPV+bOPV |
| Biological |
2+1 sequential" immunization program (wIPV-wIPV-bOPV) |
|
| The seropositive rates of poliovirus type I, type II and type III neutralizing antibody | Day 30 post full vaccination |
| The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64 | Day 30 post full vaccination |
| Incidence of adverse reactions/events | 30 days after each dose of vaccination |
| Incidence of serious adverse events (SAE) | From the first immunization to 6 months after the last immunization |
| 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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