Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice

Beijing Chaoyang District Centre for Disease Control and Prevention

Status: Unknown

Conditions: Cervical Cancer

Treatments: Biological: HPV 4

Study type: Observational

Funder types: Other

Identifiers

NCT03659110

cycdc2018-1

Details and patient eligibility

About

This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening

Exclusion criteria

1. Unable to provide written informed consent
2. Any woman who is known being pregnant at screening
3. Subject who is participating or going to participate in another study which involves GARDASIL administration

Trial design

1,000 participants in 1 patient group

1000 subjects receive the HPV 4 vaccine

Treatment:

Biological: HPV 4