Infections, PapillomavirusPhase 3NCT00811798
Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
A Phase 3 study testing Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in Hong Kong.
Trial summary
This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241). Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Cervarix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide [Al(OH)3]).
- A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday.
- Written informed consent obtained from the subject (prior to enrolment).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must have a negative urine pregnancy test.
- Subjects must be of non-childbearing potential or, if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for two months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
- Pregnant or breastfeeding.
- Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
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- Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Previous administration of an adjuvant that used in the HPV-16/18 vaccine.
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
- Acute disease at the time of enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Subjects.
This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
- Conditions
- Infections, Papillomavirus
- Being tested
- Cervarix
- Keywords
- Hong Kong, Human papillomavirus, Safety
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervarixBiological
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix Group | Experimental | Not described Receives: Biological: Cervarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: During the entire study period (Day 0 up to the telephone contact at Month 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 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
- NCT00811798
- Sponsor's protocol ID
- 111712
- Status last verified
- Sep 2016
- First submitted
- 18 Dec 2008
- Last updated
- 20 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Subjects.
- ClinicalTrials.gov ID
- NCT00811798
- Acronym / sponsor ID
- 111712
- Conditions
- Infections, Papillomavirus
- Keywords
- Hong Kong, Human papillomavirus, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 13 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervarix Group | Experimental | Biological: Cervarix |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide [Al(OH)3]).
- A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday.
- Written informed consent obtained from the subject (prior to enrolment).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must have a negative urine pregnancy test.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
- Pregnant or breastfeeding.
- Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
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 |
|---|---|---|
| CervarixSubjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule. | Biological | Cervarix Group |
Primary outcome
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
Time frame: During the entire study period (Day 0 up to the telephone contact at Month 12).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in Hong Kong.
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 6 inclusion and 12 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. (time frame: During the entire study period (Day 0 up to the telephone contact at Month 12).). 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 20 Oct 2016.