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This study is intended to support the registration of IMOVAX Polio in China.
The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poliomyelitis Vaccine inactivated | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine | 1 month post-vaccination 3 |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety of IMOVAX Polio™ vaccine | Entire study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guilin | 541001 | China | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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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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| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| D023321 | Poliovirus Vaccines |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) | Biological | 1g dragee, oral |
|
|
| PingLe County |
| 542400 |
| China |
| 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 |
| D014765 |
| Viral Vaccines |