Last updated: 11/03/2018 16:28:32

Drug Use Investigation for Cervarix®

GSK study ID
114332
See study documents
Clinicaltrials.gov ID
NCT01187927
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for Cervarix®
Trial description: This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of subjects with solicited local adverse events

Timeframe: 7 days after vaccination

The number of subjects with solicited general adverse events

Timeframe: 7 days after vaccination

The number of subjects with unsolicited adverse events

Timeframe: 30 days after vaccination

The number of subjects with serious adverse events

Timeframe: 30 days after vaccination

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Cervarix®
    • Enrollment:
    1230
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to January 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    10+ years
    Accepts healthy volunteers
    Yes
    • Subject must be female
    • Subject must be aged 10 and over
    • Subject with obvious fever
    • Subject with obvious severe acute disease
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-30-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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