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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111 1115 6566 | Other Identifier | WHO |
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The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China.
Objective:
To describe serious adverse events 30 days after each dose of IMOVAX Polioâ„¢ administered at 2, 3, and 4 months of age among infants living in the study cities of China.
Each study participant will receive an IMOVAX Polioâ„¢ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants receiving their first dose of polio vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMOVAX Polioâ„¢: Inactivated Poliomyelitis Vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. | A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event. | Up to 30 days after each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | Beijing Municipality | 100050 | 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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| Changsha |
| China |
| Chengdu | China |
| Chongqing | China |
| Hangzhou | China |
| Jinan | China |
| Kunming | China |
| Nanjing | China |
| Qingdao | China |
| Shenyang | China |
| Shenzhen | China |
| Tianjin | China |
| Wuhan | China |
| Xi'an | China |
| Zheng Zho | 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 |