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COMPLETEDNCT06824896

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Ⓡ).

Lead sponsor: Xiamen Innovax Biotech Co., Ltd•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Xiamen Innovax Biotech Co., Ltd

Collaborators

Xiamen University
Xiamen Health and Medical Big Data Center

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Ⓡ.

Age

9 - 45 years

Sex

FEMALE

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

•\-

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 13, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment1,322,084

Start dateJun 2023

Last updatedFeb 13, 2025

Condition

Autoimmune Diseases Adverse Pregnancy Outcomes

Locations shown

Xiamen Innovax Biotech Co., Ltd

Xiamen, Fujian

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2025Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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