Infections, PapillomavirusPhase 3NCT00849381
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand
A Phase 3 study testing GSK580299, GSK Biological's HPV vaccine in people with Infections, Papillomavirus, run by GlaxoSmithKline at 9 sites in 3 countries.
Trial summary
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine). Read more about this study
- Who is it for?
- Ages 26 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- GSK580299, GSK Biological's HPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,239 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Apr 2009to Dec 2012
- 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 26 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study
- A subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot receive commercially available HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure in the subject's country or because the subject is above the age for which the vaccine is licensed.
- Written informed consent must be obtained from the subject prior to enrolment.
- A woman aged 26 years or older at the time of the first vaccination in this study.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
- Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Who cannot join
- Pregnant or lactating female. Enrolment should be deferred until three months after pregnancy has been completed or after lactating has ceased.
- A woman planning to become pregnant or likely to become pregnant or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the extended safety follow-up 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).
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen by protocol.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days (i.e. Day 0-29) of each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
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- Previous administration of components of the investigational vaccine.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex.
- Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests, which in the opinion of the investigator precludes administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Cancer or autoimmune disease under treatment.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Acute disease at the time of enrolment.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Brazil3 sites
GSK Investigational Site
Campinas, 13083-970
GSK Investigational Site
Curitiba, 80060-150
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003
Taiwan3 sites
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Taipei, 114
Thailand3 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Bangkok, 10700
About this study
Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).
- Conditions
- Infections, Papillomavirus
- Being tested
- GSK580299, GSK Biological's HPV vaccine
- Keywords
- HPV, HPV vaccine, papillomavirus, cervical cancer, human papillomavirus
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK580299, GSK Biological's HPV vaccineBiological
Also called CervarixTM
All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix Compliance Issue Centre Group | Experimental | Subjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study Receives: Biological: GSK580299, GSK Biological's HPV vaccine |
| Cervarix All Centres Group | Experimental | Subjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. Receives: Biological: GSK580299, GSK Biological's HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Note: Results from one center where compliance issues were discovered are presented also separately.
Measured: During the entire study period (up to Month 12)
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: During the entire study period (up to Month 12)
Number of Subjects With Pregnancies and Pregnancy Outcomes
The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.
Measured: During the entire study period (up to Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2012
- Study completionDec 2012
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,239 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
- NCT00849381
- Sponsor's protocol ID
- 111758
- Status last verified
- Aug 2014
- First submitted
- 19 Feb 2009
- Last updated
- 12 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008
- ClinicalTrials.gov ID
- NCT00849381
- Acronym / sponsor ID
- 111758
- Conditions
- Infections, Papillomavirus
- Keywords
- HPV, HPV vaccine, papillomavirus, cervical cancer, human papillomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,239 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervarix Compliance Issue Centre Group | Experimental | Biological: GSK580299, GSK Biological's HPV vaccineSubjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study |
| Cervarix All Centres Group | Experimental | Biological: GSK580299, GSK Biological's HPV vaccineSubjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. |
Who may qualify
- Ages
- 26 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study
- A subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot receive commercially available HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure in the subject's country or because the subject is above the age for which the vaccine is licensed.
- Written informed consent must be obtained from the subject prior to enrolment.
- A woman aged 26 years or older at the time of the first vaccination in this study.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (14 listed)
- Pregnant or lactating female. Enrolment should be deferred until three months after pregnancy has been completed or after lactating has ceased.
- A woman planning to become pregnant or likely to become pregnant or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the extended safety follow-up 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).
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen by protocol.
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 |
|---|---|---|
| GSK580299, GSK Biological's HPV vaccineAlso: CervarixTMAll subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule. | Biological | Cervarix All Centres Group, Cervarix Compliance Issue Centre Group |
Primary outcome
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (up to Month 12)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Results from one center where compliance issues were discovered are presented also separately.
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: During the entire study period (up to Month 12)
MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Number of Subjects With Pregnancies and Pregnancy Outcomes
Time frame: During the entire study period (up to Month 12)
The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK580299, GSK Biological's HPV vaccine in people with Infections, Papillomavirus, run by GlaxoSmithKline at 9 sites in 3 countries.
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 7 inclusion and 14 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil, Taiwan, Thailand. 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 25 Aug 2014). 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 With Any, Grade 3 and Related Serious Adverse Events (SAEs) (time frame: During the entire study period (up to Month 12)). The study lists 3 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 12 Sep 2014.