Drug Use Investigation for Cervarix®
N/A
10 Years
N/A
10 Years
N/A
Open (Enrolling)
Female
Papillomavirus Vaccines, Human Papillomavirus Infection, Cervical Neoplasia
Female
Papillomavirus Vaccines, Human Papillomavirus Infection, Cervical Neoplasia
Trial Information
Drug Use Investigation for Cervarix®
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
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
The number of subjects with solicited local adverse events
Outcome Description:
Local adverse events: pain, redness, swelling at the vaccination site
Outcome Time Frame:
7 days after vaccination
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
114332
NCT ID:
NCT01187927
Start Date:
September 2010
Completion Date:
June 2013
Related Keywords:
- Papillomavirus Vaccines
- Human Papillomavirus Infection
- Cervical Neoplasia
- Neoplasms
- Warts
- Papillomavirus Infections
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