Drug Use Investigation for Cervarix®
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 20, 2010
Last updated: October 4, 2012
Last verified: September 2012
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
Human Papillomavirus Infection
|Study Design:||Time Perspective: Prospective|
|Official Title:||Drug Use Investigation for Cervarix®|
Resource links provided by NLM:
U.S. FDA Resources
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 ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Subjects received Cervarix® as per routine practice
Administered according to the prescribing information in the locally approved label by the authorities.
Contacts and Locations