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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06824896

Acronym

HPV-PRO-013

Enrollment

1322084

Registered

2025-02-13

Start date

2023-06-06

Completion date

2024-06-30

Last updated

2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Pregnancy Outcomes, Autoimmune Diseases

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Ⓡ.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

9 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results