Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice
- Conditions
- Cervical Cancer
- Interventions
- Biological: HPV 4
- Registration Number
- NCT03659110
- Lead Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Brief Summary
This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1000
Inclusion Criteria
- Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening
Exclusion Criteria
- Unable to provide written informed consent
- Any woman who is known being pregnant at screening
- Subject who is participating or going to participate in another study which involves GARDASIL administration
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1000 subjects receive the HPV 4 vaccine HPV 4 -
- Primary Outcome Measures
Name Time Method Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice 24 months 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
Number of participants with adverse events following any dose of vaccine within 30 days after each dose Number of participants with adverse events following any dose of vaccine
- Secondary Outcome Measures
Name Time Method