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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03659110
• Other study ID #: cycdc2018-1
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2018
• Source: Beijing Chaoyang District Centre for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• HPV 4
1000 subjects will be received the HPV 4 vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chaoyang District Centre for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice	Adverse reactions associated with vaccine will be observed in females Aged 20-45 Years after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy	24 months
Primary	Number of participants with adverse events following any dose of vaccine	Number of participants with adverse events following any dose of vaccine	within 30 days after each dose