Drug Use Investigation for Cervarix®

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01187927
First received: August 20, 2010
Last updated: December 5, 2013
Last verified: December 2013
  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®

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Any symptoms other than specified (local/systemic) symptoms

  • The number of subjects with serious adverse events [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Study Completion Date: January 2014
Estimated 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

Ages Eligible for Study:   10 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187927

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01187927     History of Changes
Other Study ID Numbers: 114332
Study First Received: August 20, 2010
Last Updated: December 5, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on September 22, 2014