NCT06824896

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,322,084

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

January 24, 2025

Last Update Submit

February 7, 2025

Conditions

Autoimmune DiseasesAdverse Pregnancy Outcomes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • other serious diseases

    through study completion, around 7.3 years

Study Arms (2)

premarketing corhort

females aged 9-45 years during premarketing observation of CecolinⓇ

postmarketing corhort

females aged 9-45 years during postmarketing observation of CecolinⓇ

Eligibility Criteria

Age9 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiamen Innovax Biotech Co., Ltd

Xiamen, Fujian, 361022, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 13, 2025

Study Start

June 6, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)