Drug Use Investigation for Cervarix®

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

Study Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Biological: Cervarix®

• Study Type: Observational
• Enrollment (Actual): 1230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Japanese women who received Cervarix® for the first time

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Female subjects; Subjects received Cervarix® as per routine practice	Biological: Cervarix®; Administered according to the prescribing information in the locally approved label by the authorities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects with solicited local adverse events	Local adverse events: pain, redness, swelling at the vaccination site	7 days after vaccination
The number of subjects with solicited general adverse events	General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash	7 days after vaccination
The number of subjects with unsolicited adverse events	Any symptoms other than specified (local/systemic) symptoms	30 days after vaccination
The number of subjects with serious adverse events		30 days after vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 24, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 22, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 114332