Infections, PapillomavirusNCT01187927
Drug Use Investigation for Cervarix®
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages 10 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Cervarix®
- How many people
- 1,230 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Japanese women who received Cervarix® for the first time
Who may be able to join
- Subject must be female
- Subject must be aged 10 and over
Who cannot join
- 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
About this study
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
- Conditions
- Infections, Papillomavirus
- Being tested
- Cervarix®
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervarix®Biological
Administered according to the prescribing information in the locally approved label by the authorities.
| Study group | Role | What they receive |
|---|---|---|
| Female subjects | Subjects received Cervarix® as per routine practice Receives: Biological: Cervarix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with solicited local adverse events
Local adverse events: pain, redness, swelling at the vaccination site
Measured: 7 days after vaccination
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
Measured: 7 days after vaccination
The number of subjects with unsolicited adverse events
Any symptoms other than specified (local/systemic) symptoms
Measured: 30 days after vaccination
The number of subjects with serious adverse events
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187927
- Sponsor's protocol ID
- 114332
- Status last verified
- Jan 2015
- First submitted
- 20 Aug 2010
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for Cervarix®
- ClinicalTrials.gov ID
- NCT01187927
- Acronym / sponsor ID
- 114332
- Conditions
- Infections, Papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female subjects | – | Biological: Cervarix®Subjects received Cervarix® as per routine practice |
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese women who received Cervarix® for the first time
Key inclusion criteria (2 listed)
- Subject must be female
- Subject must be aged 10 and over
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervarix®Administered according to the prescribing information in the locally approved label by the authorities. | Biological | Female subjects |
Primary outcome
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
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
The number of subjects with unsolicited adverse events
Time frame: 30 days after vaccination
Any symptoms other than specified (local/systemic) symptoms
The number of subjects with serious adverse events
Time frame: 30 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with solicited local adverse events (time frame: 7 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015; AzTrials last refreshed its copy on 26 Oct 2026.