Cervical Cancer
Conditions
Keywords
vaccine, safety
Brief summary
This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.
Interventions
BIOLOGICALHPV 4
1000 subjects will be received the HPV 4 vaccine
Sponsors
Beijing Chaoyang District Centre for Disease Control and Prevention
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed