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

Completed

• Conditions: Autoimmune Diseases; Adverse Pregnancy Outcomes

• Registration Number: NCT06824896
• Lead Sponsor: Xiamen Innovax Biotech Co., Ltd

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2023-06-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Study First Submitted: 2025-01-24
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1322084

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.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
autoimmune conditions	through study completion, around 7.3 years	incidence of autoimmune conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic
adverse pregnancy conditions	through study completion, around 7.8 years	incidence of the adverse pregnancy outcomes in maternal, fetal and neonatal

Secondary Outcome Measures

Name	Time	Method
other serious diseases	through study completion, around 7.3 years	incidence of primary ovarian insufficiency, facial paralysis, complex regional pain syndrome and postural orthostatic tachycardia syndrome.

Trial Locations

Locations (1)

Xiamen Innovax Biotech Co., Ltd; 🇨🇳 Xiamen, Fujian, China