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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Shandong Province Centers for Disease Control and Prevention | OTHER |
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In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort to evaluate the proportion of seroprotection of antibody and measure neutralizing antibody titers against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.
Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort when all subjects are at least 18 months old to monitor persistence of antibody. So that, if the antibody levels are not high enough to protect children from the disease, remedial measures can be taken as soon as possible.So China CDC conduct this follow up study ,to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three-dose schedule for Sabin IPV | Subjects already vaccinated Sabin IPV at 2, 3, and 4 months of age, collected two blood samples and laboratory test results were available. |
| |
| Two-dose schedule for Sabin IPV | Subjects already vaccinated Sabin IPV at 4 and 8-11 months of age, collected two blood samples and laboratory test results were available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin strain inactivated polio vaccine | Biological | Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody persistence | Evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody titers | Measure neutralizing antibody titers against poliovirus type I, II and III at over 18 months of age infants after 2-dose Sabin IPV schedule, compared with 3-dose Sabin IPV schedule | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Children who had participated the previous Sabin IPV study in 6 counties in Shandong province.
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| Name | Affiliation | Role |
|---|---|---|
| Zijian Feng, MD | Centers for Disease Control and Prevention, China | Study Chair |
| Zhijie An, MPH | Centers for Disease Control and Prevention, China | Principal Investigator |
| Zundong Yin | Centers for Disease Control and Prevention, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Center for Disease Control and Prevention | Jinan | China |
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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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Serum
| 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 |