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| Name | Class |
|---|---|
| Xiamen University | OTHER |
| Xiamen Health and Medical Big Data Center | UNKNOWN |
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This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).
This study was initiated following the approval of the Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) (CecolinⓇ) in China. We undertook a retrospective-prospective real-world study to assess the incidence of new-onset autoimmune conditions (10 conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic) and adverse pregnancy conditions (e.g., premature birth, birth defects) among 9-45 yoa females during the pre- and post-marketing period of CecolinⓇ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| premarketing corhort | females aged 9-45 years during premarketing observation of CecolinⓇ | ||
| postmarketing corhort | females aged 9-45 years during postmarketing observation of CecolinⓇ |
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| Measure | Description | Time Frame |
|---|---|---|
| autoimmune conditions | incidence of autoimmune conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic | through study completion, around 7.3 years |
| adverse pregnancy conditions | incidence of the adverse pregnancy outcomes in maternal, fetal and neonatal | through study completion, around 7.8 years |
| Measure | Description | Time Frame |
|---|---|---|
| other serious diseases | incidence of primary ovarian insufficiency, facial paralysis, complex regional pain syndrome and postural orthostatic tachycardia syndrome. | through study completion, around 7.3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Innovax Biotech Co., Ltd | Xiamen | Fujian | 361022 | China |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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