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Drug Use Investigation for Cervarix®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187927
First Posted: August 24, 2010
Last Update Posted: January 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.

Condition Intervention
Infections, Papillomavirus Biological: Cervarix®

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for Cervarix®

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of subjects with solicited local adverse events [ Time Frame: 7 days after vaccination ]
    Local adverse events: pain, redness, swelling at the vaccination site

  • The number of subjects with solicited general adverse events [ Time Frame: 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 [ Time Frame: 30 days after vaccination ]
    Any symptoms other than specified (local/systemic) symptoms

  • The number of subjects with serious adverse events [ Time Frame: 30 days after vaccination ]

Enrollment: 1230
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Japanese women who received Cervarix® for the first time
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187927


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01187927     History of Changes
Other Study ID Numbers: 114332
First Submitted: August 20, 2010
First Posted: August 24, 2010
Last Update Posted: January 26, 2015
Last Verified: January 2015