A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ (HPV-PRO-013)

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

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

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases; Adverse Pregnancy Outcomes

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 Type: Observational
• Enrollment (Actual): 1322084

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361022
      • Xiamen Innovax Biotech Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
premarketing corhort; females aged 9-45 years during premarketing observation of CecolinⓇ
postmarketing corhort; females aged 9-45 years during postmarketing observation of CecolinⓇ

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiamen Innovax Biotech Co., Ltd
• Collaborators: Xiamen University; Xiamen Health and Medical Big Data Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: HPV-PRO-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No