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The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd. Intervention: investigational sIPV |
|
| Control Group | Active Comparator | The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational sIPV | Biological | Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rates (SCRs) of each group after primary immunization. | 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. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2). | 90 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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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pizhou County Center for Disease Control and Prevention | Pizhou | Jiangsu | 221300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30958543 | Derived | Hu Y, Wang J, Zeng G, Chu K, Jiang D, Zhu F, Ying Z, Chen L, Li C, Zhu F, Yin W. Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial. J Infect Dis. 2019 Oct 8;220(10):1551-1557. doi: 10.1093/infdis/jiy736. |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| Control IPV | Biological | Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV |
|
Unsolicited AEs occurred within 30 days after each injection will be collected.
| 30 days |
| The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group. | SAEs during the period of safety monitoring will be collected. | 90-420 days. |
| The post-immune antibody positive rate of each group after primary immunization. | Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2). | 90 days |
| The post-immune geometric mean titer (GMT) of each group after primary immunization. | GMT of each group after primary immunization which lasts 60 days. | 90 days. |
| The geometric mean fold increase (GMI) of each group after primary immunization. | The GMI is the increase of post-immune GMT from pre-immune GMT. | 90 days |
| The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization. | Percentage of subjects with antibody ≥ 1:64 of each group after three-dose | 90 days |
| The antibody positive rate of each group before booster dose. | Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months. | 420 days |
| The geometric mean titer (GMT) of each group before booster dose. | GMT of each group before booster dose which occurred at the age of 18months. | 420 days. |
| The geometric mean fold increase (GMI) of each group before booster dose. | The GMI is the increase of post-immune GMT from pre-i mmune GMT. | 420 days |
| The percentage of subjects with antibody ≥ 1:64 of each group before booster dose. | Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months. | 420 days |
| The post-immune antibody positive rate of each group after booster dose. | Subjects whose post-immune antibody level ≥ 1:8 are co nsidered antibody positive | 570 days |
| The post-immune geometric mean titer (GMT) of each group after booster dose. | GMT of each group after booster dose. The booster dose at the age of 18months | 570 days |
| The geometric mean fold increase (GMI) of each group after booster dose. | The GMI is the increase of post-immune GMT from pre-immune GMT. | 570 days |
| The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose. | Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months. | 570 days |
| 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 |