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

Xiamen Innovax Biotech

Status

Completed

Conditions

Adverse Pregnancy Outcomes

Autoimmune Diseases

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06824896

HPV-PRO-013

Details and patient eligibility

About

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

Full 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Ⓡ.

Enrollment

1,322,084 patients

Sex

Female

Ages

9 to 45 years old

Volunteers

Accepts Healthy Volunteers

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