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
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 April 17, 2014