Infections, PapillomavirusPhase 3NCT01418937
Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
A Phase 3 study testing CervarixTM (GSK580299) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 5 sites in Brazil.
Trial summary
This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study. 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?
- CervarixTM (GSK580299)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 5 sitesBrazil
- Study dates
- 29 May 2012to 9 Jan 2015
- 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 can and will comply with the requirements of the protocol.
- A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older.
- Written informed consent must be obtained from the subject prior to enrollment.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Who cannot join
- Pregnant or breastfeeding: enrollment should be deferred to at least three months after delivery and after breastfeeding is ceased.
- A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, and up to two months after the last vaccine dose.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of the vaccine, with the exception of 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. Enrollment will be deferred until the subject is outside of specified window.
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- 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 a non-investigational product.
- Previous administration of vaccine components.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Cancer or autoimmune disease under treatment.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrollment. Enrollment will be deferred until condition is resolved.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
GSK Investigational Site
Campinas, 13083-970
GSK Investigational Site
Curitiba, 80060-150
GSK Investigational Site
Fortaleza, 60135-225
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035003
GSK Investigational Site
São Paulo, 03015000
About this study
Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study
This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.
- Conditions
- Infections, Papillomavirus
- Being tested
- CervarixTM (GSK580299)
- Keywords
- HPV vaccine, serious adverse events (SAEs), medically significant conditions, cervical neoplasia
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervarixTM (GSK580299)Biological
Three intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| HPV Group | Experimental | Not described Receives: Biological: CervarixTM (GSK580299) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Throughout the study period (from Month 0 up to Month 12)
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Measured: Throughout the study period (from Month 0 up to Month 12)
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs include AEs 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: Throughout the study period (from Month 0 up to Month 12)
Number of Pregnant Subjects Reporting Pregnancy Outcomes
The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Measured: Throughout the study period (from Month 0 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 posted17 Aug 2011 (estimated)
- Study start29 May 2012
- Primary completion9 Jan 2015
- Study completion9 Jan 2015
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
- 164 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
- NCT01418937
- Sponsor's protocol ID
- 114379
- Status last verified
- Jun 2018
- First submitted
- 12 Aug 2011
- Last updated
- 12 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. 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 Control Subjects From the GSK HPV-023 Study
- ClinicalTrials.gov ID
- NCT01418937
- Acronym / sponsor ID
- 114379
- Conditions
- Infections, Papillomavirus
- Keywords
- HPV vaccine, serious adverse events (SAEs), medically significant conditions, cervical neoplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 May 2012
- Primary completion
- 9 Jan 2015 (actual)
- Study completion
- 9 Jan 2015 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Posted 21 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV Group | Experimental | Biological: CervarixTM (GSK580299) |
Who may qualify
- Ages
- 26 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older.
- Written informed consent must be obtained from the subject prior to enrollment.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding: enrollment should be deferred to at least three months after delivery and after breastfeeding is ceased.
- A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, and up to two months after the last vaccine dose.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
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 |
|---|---|---|
| CervarixTM (GSK580299)Three intramuscular injections | Biological | HPV Group |
Primary outcome
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the study period (from Month 0 up to Month 12)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Time frame: Throughout the study period (from Month 0 up to Month 12)
Number of Subjects With Medically Significant Conditions (MSCs)
Time frame: Throughout the study period (from Month 0 up to Month 12)
MSCs include AEs 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 Pregnant Subjects Reporting Pregnancy Outcomes
Time frame: Throughout the study period (from Month 0 up to Month 12)
The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CervarixTM (GSK580299) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 5 sites in Brazil.
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 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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 21 Aug 2015). 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 Serious Adverse Events (SAEs) (time frame: Throughout the study period (from Month 0 up to Month 12)). 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 12 Jul 2018.