An observational study in Autoimmune Diseases and Adverse Pregnancy Outcomes, sponsored by Xiamen Innovax Biotech Co., Ltd. Completed at 1 site in China. Open to female participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Xiamen Innovax Biotech Co., Ltd · Observational
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Ⓡ.
802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.
This study's enrollment of 1,322,084 is above the median of 300 across 229 observational studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Xiamen Innovax Biotech Co., Ltd is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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females aged 9-45 years during premarketing observation of CecolinⓇ
females aged 9-45 years during postmarketing observation of CecolinⓇ
autoimmune conditions
incidence of autoimmune conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic
Time frame: through study completion, around 7.3 years
adverse pregnancy conditions
incidence of the adverse pregnancy outcomes in maternal, fetal and neonatal
Time frame: through study completion, around 7.8 years
other serious diseases
incidence of primary ovarian insufficiency, facial paralysis, complex regional pain syndrome and postural orthostatic tachycardia syndrome.
Time frame: through study completion, around 7.3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Xiamen Innovax Biotech Co., Ltd