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| Name | Class |
|---|---|
| Beijing Minhai Biotechnology Co., Ltd | INDUSTRY |
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This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group - High dosage | Experimental | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV |
|
| Experimental Group - Medium dosage | Experimental | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV |
|
| Experimental Group - Low dosage | Experimental | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV |
|
| Control Group -commercialized sIPV | Active Comparator | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV |
|
| Control Group -commercialized IPV |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three-dose regimen of high dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rates (SCRs) of each group after three-dose regimen | Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. | 28~42 days |
| The post-immune geometric mean titer (GMT) of each group after three-dose regimen | GMT of each group 28~42 days after three-dose regimen. | 28~42 days |
| The geometric mean fold increase (GMI) of each group after three-dose regimen | The GMI is the increase of post-immune GMT from pre-immune GMT. | 28~42 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidences of solicited adverse events (AEs) of each group | Solicited AEs occurred within 7 days after each injection will be collected. | 7 days |
| The incidences of unsolicited adverse events (AEs) of each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32867698 | Derived | Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1. |
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Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV |
|
| Three-dose regimen of medium dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. |
|
| Three-dose regimen of low dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. |
|
| Three-dose regimen of commercialized sIPV | Biological | The control vaccine was manufactured by Chinese Academy of Medical Sciences. |
|
| Three-dose regimen of commercialized IPV | Biological | The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO). |
|
Unsolicited AEs occurred within 30 days after each injection will be collected.
| 30 days |
| The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 30 days after each injection will be collected. | 30 days |
| ID | Term |
|---|---|
| D016262 | Postpoliomyelitis Syndrome |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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