A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1322084 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-06-30

Brief Summary

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This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).

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Detailed Description

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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Ⓡ.

Conditions

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Autoimmune Diseases Adverse Pregnancy Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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premarketing corhort

females aged 9-45 years during premarketing observation of CecolinⓇ

No interventions assigned to this group

postmarketing corhort

females aged 9-45 years during postmarketing observation of CecolinⓇ

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center;
* Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.