Overview

This trial is active, not recruiting.

Condition infections, papillomavirus
Treatment cervarix®
Sponsor GlaxoSmithKline
Start date September 2010
End date January 2014
Trial size 1000 participants
Trial identifier NCT01187927, 114332

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
Arm
Subjects received Cervarix® as per routine practice
cervarix®
Administered according to the prescribing information in the locally approved label by the authorities.

Primary Outcomes

Measure
The number of subjects with solicited local adverse events
time frame: 7 days after vaccination
The number of subjects with solicited general adverse events
time frame: 7 days after vaccination
The number of subjects with unsolicited adverse events
time frame: 30 days after vaccination
The number of subjects with serious adverse events
time frame: 30 days after vaccination

Eligibility Criteria

Female participants at least 10 years old.

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

Additional Information

Official title Drug Use Investigation for Cervarix®
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.