Infections, PapillomavirusPhase 3NCT00799825

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

A Phase 3 study testing GSK Biological's HPV vaccine GSK580299 (Cervarix™) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 580299/008 and received the control vaccine (Hepatitis A vaccine). Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: GSK Biological's HPV vaccine GSK580299 (Cervarix™)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 346 participants
Where: 48 sitesin 2 countries
Study dates: 1 Jan 2009to 2 Aug 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 18 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 18 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 (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.
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.

Show all 14Show fewer

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

48 sites in 2 countries.

Country

City, postcode or hospital

48 sites in 2 countries

United States39 sites

GSK Investigational Site
Albuquerque, New Mexico, 87131
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Augusta, Georgia, 30912-3500
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Chapel Hill, North Carolina, 27514
GSK Investigational Site
Charlottesville, Virginia, 22903
GSK Investigational Site
Clearwater, Florida, 33759
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Erie, Pennsylvania, 16507
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Honolulu, Hawaii, 96826
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Louisville, Colorado, 80027
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Morristown, New Jersey, 07962
GSK Investigational Site
New Bern, North Carolina, 28562
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19114
GSK Investigational Site
Pleasant Hills, Pennsylvania, 15236
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Poughkeepsie, New York, 12601
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Spokane, Washington, 99202
GSK Investigational Site
Tulsa, Oklahoma, 74105
GSK Investigational Site
Webster, Texas, 77598
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Canada9 sites

GSK Investigational Site
Beauport, Quebec, G1E 7G9
GSK Investigational Site
Edmonton, Alberta, T6G 2C8
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8
GSK Investigational Site
Langley, British Columbia, V3A 4H9
GSK Investigational Site
Montreal, Quebec, H2K 4L5
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Waterloo, Ontario, N2J 1C4
GSK Investigational Site
Winnipeg, Manitoba, R3E 0J9

Other trials in Canada

About this study

Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

Conditions: Infections, Papillomavirus
Being tested: GSK Biological's HPV vaccine GSK580299 (Cervarix™)
Keywords: papillomavirus, HPV vaccine, cervical cancer, HPV, 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.

GSK Biological's HPV vaccine GSK580299 (Cervarix™)Biological
Also called CervarixTM
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

Study groups in NCT00799825
Study group	Role	What they receive
Cervarix group	Experimental	Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule. Receives: Biological: GSK Biological's HPV vaccine GSK580299 (Cervarix™)

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. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.
Measured: Throughout the study (up to Month 12)
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.
Measured: Throughout the study (up to Month 12)
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Measured: Throughout the study (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.

1 Jan 20092 Aug 2012

First posted1 Dec 2008 (estimated)
Study start1 Jan 2009
Primary completion2 Aug 2012
Study completion2 Aug 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 346 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00799825
Sponsor's protocol ID: 111955
Status last verified: Jun 2018
First submitted: 26 Nov 2008
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infections, Papillomavirus trials

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 (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008
ClinicalTrials.gov ID: NCT00799825
Acronym / sponsor ID: 111955
Conditions: Infections, Papillomavirus
Keywords: papillomavirus, HPV vaccine, cervical cancer, HPV, human papillomavirus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 346 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Jan 2009
Primary completion: 2 Aug 2012 (actual)
Study completion: 2 Aug 2012 (actual)
First posted: 1 Dec 2008 (estimated)
Results: Posted 20 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: GSK Biological's HPV vaccine GSK580299 (Cervarix™)Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.

Who may qualify

Ages: 18 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 18 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 (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.
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
GSK Biological's HPV vaccine GSK580299 (Cervarix™)Also: CervarixTMAll subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.	Biological	Cervarix group

Primary outcome

Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Time frame: Throughout the study (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. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: Throughout the study (up to Month 12)
MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Time frame: Throughout the study (up to Month 12)

Results and safety

Results posted to the registry on 20 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cervarix Group	344	296

Primary outcome: Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)

Time frame: Throughout the study (up to Month 12). Number. Unit: Subjects

Measure	Cervarix Group n = 344
Any SAEs	8
Grade 3 SAEs	5
Related SAEs	0

Population analysed: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)

Time frame: Throughout the study (up to Month 12). Number. Unit: Subjects

Measure	Cervarix Group n = 344
Any MSCs	32
Grade 3 MSCs	9
Related MSCs	0

Primary outcome: Number of Subjects With Pregnancies and Pregnancy Outcomes.

Time frame: Throughout the study (up to Month 12). Number. Unit: Subjects

Measure	Cervarix Group n = 19
Live infant NO apparent congenital anomaly	14
Elective termination NO apparent congenital anom.	2
Spontaneous abortion NO apparent congenital anom.	2
Lost to follow up	1

Population analysed: The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

Adverse events

Time frame: SAEs were reported throughout the study period, from Day 0 up to Month 12.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	8 of 344 (2.3%)	0 of 344 (0%)	Not reported

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.

Related trials for Infections, Papillomavirus

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
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Active, not recruitingPhase 4
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Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
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Head and Neck Cancer, Head and Neck Squamous Cell Cancer

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

48 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Biological's HPV vaccine GSK580299 (Cervarix™) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 48 sites in 2 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 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 48 sites in United States, Canada. 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 20 Sep 2013). 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: Throughout the study (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?

On the ClinicalTrials.gov record for NCT00799825.

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.