An observational study in Poliomyelitis, sponsored by Centers for Disease Control and Prevention, China. Completed at 1 site in China. Open to participants aged 18 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Centers for Disease Control and Prevention, China · Observational
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Among 49 studies in Poliomyelitis with a site in China — 6 open to participants now, 7 under way, none of them phase 3. Poliomyelitis · China.
Among the 49 studies in Poliomyelitis with a site in China, this one is one of 4 that started in 2020, is one of 5 observational ones, and was the 34th registered.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
Browse Poliomyelitis studies →6 of the 49 studies in Poliomyelitis with a site in China are open now. Recruiting first, the newest first:
Institute of Medical Biology, Chinese Academy of Medical Sciences · Sites in China
Ages 2 mo–6 yrs · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 3 mo–50 yrs · Healthy volunteers
Jiangsu Province Centers for Disease Control and Prevention · Sites in China
Ages 19 mo–22 mo · Healthy volunteers
China National Biotec Group Company Limited · Sites in China
Healthy volunteers
Institute of Medical Biology, Chinese Academy of Medical Sciences · Sites in China
Ages 2 mo–2 mo · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 11 Poliomyelitis studies recruiting now, none (0%) set no upper age limit and 11 (100%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Months to 3 Years · all sexes · healthy volunteers too.
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49 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 5 · Phase 3 19 · Phase 4 16
First in 2005; this study’s year is marked. 4 started in 2020.
This study's enrollment of 774 is above the median of 600 across 21 observational studies indexed under Poliomyelitis.
Median enrollment 747 across the 44 interventional studies, 600 across the 5 observational. Of the 41 that completed or were terminated, 6 (15%) have results posted.
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29 of 49 have an industry lead sponsor. The 10 most frequent:
Centers for Disease Control and Prevention, China is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Centers for Disease Control and Prevention, China has 4 studies filed under Poliomyelitis — fewer than ten, so there is no comparison to draw.
2 of the studies in Poliomyelitis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07338851China National Biotec Group Company Limitedthe Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines | 2026-12-31 |
| NCT07891104Institute of Medical Biology, Chinese Academy of Medical SciencesA Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed | 2027-08-16 |
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Among the 49 studies in Poliomyelitis with a site in China, from their registry updates:
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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
Children who had participated the previous Sabin IPV study in 6 counties in Shandong province.
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Exclusion Criteria:
Subjects already vaccinated Sabin IPV at 2, 3, and 4 months of age, collected two blood samples and laboratory test results were available.
Biological: Sabin strain inactivated polio vaccine
Subjects already vaccinated Sabin IPV at 4 and 8-11 months of age, collected two blood samples and laboratory test results were available.
Biological: Sabin strain inactivated polio vaccine
Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months.
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.
Time frame: 1 month
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
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Dec 2021, 13 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centers for Disease Control and Prevention, China