Drug Use Investigation for Cervarix®

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix®

Study type: Observational

Funder types: Industry

Identifiers

NCT01187927

114332

Details and patient eligibility

About

This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.

Enrollment: 1,230 patients

Sex: Female

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,230 participants in 1 patient group

Female subjects

Description:

Subjects received Cervarix® as per routine practice

Treatment:

Biological: Cervarix®