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Completed

NCT Number: NCT06824896

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

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

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Key information

Conditions

Autoimmune Diseases Adverse Pregnancy Outcomes Immune System Diseases

Age range

9 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Xiamen Innovax Biotech Co., Ltd

Xiamen, Fujian, 361022, China

About this study

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Ⓡ.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. autoimmune conditions

    Time frame: through study completion, around 7.3 years

    incidence of autoimmune conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic

  2. adverse pregnancy conditions

    Time frame: through study completion, around 7.8 years

    incidence of the adverse pregnancy outcomes in maternal, fetal and neonatal

Secondary outcomes

  1. other serious diseases

    Time frame: through study completion, around 7.3 years

    incidence of primary ovarian insufficiency, facial paralysis, complex regional pain syndrome and postural orthostatic tachycardia syndrome.

Sponsors and collaborators

Lead sponsor

Xiamen Innovax Biotech Co., Ltd

Industry

Collaborators

  • Xiamen Health and Medical Big Data Center
  • Xiamen University

Registry information

Official study title

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

Acronym: HPV-PRO-013

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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