Last updated: 11/03/2018 16:28:32
Drug Use Investigation for Cervarix®
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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
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