Drug Use Investigation for Cervarix®

NCT ID: NCT01187927

Last Updated: 2015-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Infections, Papillomavirus

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Female subjects

Subjects received Cervarix® as per routine practice

Cervarix®

Intervention Type BIOLOGICAL

Administered according to the prescribing information in the locally approved label by the authorities.

Interventions

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Cervarix®

Administered according to the prescribing information in the locally approved label by the authorities.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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114332

Identifier Type: -

Identifier Source: org_study_id

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