Drug Use Investigation for Cervarix®
Completed
- Conditions
- Infections, Papillomavirus
- Interventions
- Biological: Cervarix®
- Registration Number
- NCT01187927
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1230
Inclusion Criteria
- Subject must be female
- Subject must be aged 10 and over
Exclusion Criteria
- Subject with obvious fever
- Subject with obvious severe acute disease
- Subject with hypersensitivity to any component of Cervarix®
- Other than above, subject who is in inappropriate conditions for vaccination
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Female subjects Cervarix® Subjects received Cervarix® as per routine practice
- Primary Outcome Measures
Name Time Method The number of subjects with solicited local adverse events 7 days after vaccination Local adverse events: pain, redness, swelling at the vaccination site
The number of subjects with solicited general adverse events 7 days after vaccination General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash
The number of subjects with unsolicited adverse events 30 days after vaccination Any symptoms other than specified (local/systemic) symptoms
The number of subjects with serious adverse events 30 days after vaccination
- Secondary Outcome Measures
Name Time Method