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Drug Use Investigation for Cervarix®

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ClinicalTrials.gov Identifier: NCT01187927
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment
Infections, Papillomavirus Biological: Cervarix®

Study Type : Observational
Actual Enrollment : 1230 participants
Time Perspective: Prospective
Official Title: Drug Use Investigation for Cervarix®
Study Start Date : September 2010
Primary Completion Date : January 2014
Study Completion Date : January 2014

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.



Primary Outcome Measures :
  1. 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

  2. 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

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

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


Information from the National Library of Medicine

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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

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

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