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Ⓡ.
Study Type
OBSERVATIONAL
Enrollment
1,322,084
Xiamen Innovax Biotech Co., Ltd
Xiamen, Fujian, China
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
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