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OpenTrials
Completed

NCT Number: NCT01187927

Drug Use Investigation for Cervarix®

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

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Key information

Conditions

Infections, Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

10 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervarix®

Biological

Administered according to the prescribing information in the locally approved label by the authorities.

Primary outcomes

  1. The number of subjects with solicited local adverse events

    Time frame: 7 days after vaccination

    Local adverse events: pain, redness, swelling at the vaccination site

  2. The number of subjects with solicited general adverse events

    Time frame: 7 days after vaccination

    General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash

  3. The number of subjects with unsolicited adverse events

    Time frame: 30 days after vaccination

    Any symptoms other than specified (local/systemic) symptoms

  4. The number of subjects with serious adverse events

    Time frame: 30 days after vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2010
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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