NCT06824896

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

An Observational Database Study to Monitor Safety-related Endpoints After Marketing of Cecolin®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,322,084 (actual)
• Sponsor: Xiamen Innovax Biotech Co., Ltd · Industry
• Sex: Female
• Age: 9 Years – 45 Years
• Healthy volunteers: Accepted

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Ⓡ.

Conditions

• Autoimmune Diseases
• Adverse Pregnancy Outcomes

Timeline

• Start date: 2023-06-06
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2025-02-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: China