Drug Use Investigation for Cervarix®

Infections, Papillomavirus Clinical Trial

Official title:

Drug Use Investigation for Cervarix®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187927
• Other study ID #: 114332
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: January 22, 2015
• Start date: September 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

Biological:
• Cervarix®
Administered according to the prescribing information in the locally approved label by the authorities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with solicited local adverse events	Local adverse events: pain, redness, swelling at the vaccination site	7 days after vaccination	No
Primary	The number of subjects with solicited general adverse events	General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash	7 days after vaccination	No
Primary	The number of subjects with unsolicited adverse events	Any symptoms other than specified (local/systemic) symptoms	30 days after vaccination	No
Primary	The number of subjects with serious adverse events		30 days after vaccination	No