Infections, PapillomavirusPhase 3NCT01190189
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
A Phase 3 study testing GSK580299 (Cervarix) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 28 sites in 2 countries.
Trial summary
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26… 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 (Cervarix)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 1 Apr 2011to 23 Nov 2017
- 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 NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
- Written informed consent obtained from the subject
- 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:
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- 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.
- A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. 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. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
- 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, 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. Enrolment 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.
- NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:
- if they test positive for oncogenic HPV infection, but display normal cervical cytology at their concluding HPV-015 study end visit;
- if they are pregnant so that no cervical sample can be taken at their concluding HPV-015 study end visit;
- Previous administration of any components of the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Cancer or autoimmune disease under treatment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- 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 enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States21 sites
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Erie, Pennsylvania, 16507
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
New Bern, North Carolina, 28562
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
Wichita, Kansas, 67207
Canada7 sites
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Québec, Quebec, G1S 2L6
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Vancouver, British Columbia, V6H 3N1
GSK Investigational Site
Waterloo, Ontario, N2L 6H6
About this study
Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.
Read the detailed description
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.
- Conditions
- Infections, Papillomavirus
- Being tested
- GSK580299 (Cervarix)
- Keywords
- Serious adverse events (SAEs), HPV vaccine, 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.
GSK580299 (Cervarix)Biological
3-dose schedule intramuscularly vaccination
| Study group | Role | What they receive |
|---|---|---|
| Cervarix Group | Experimental | Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule. Receives: Biological: GSK580299 (Cervarix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
Measured: During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
Measured: During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
Measured: During the entire study period (from Day 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 posted27 Aug 2010 (estimated)
- Study start1 Apr 2011
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
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
- 137 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
- NCT01190189
- Sponsor's protocol ID
- 113621
- Status last verified
- Jun 2019
- First submitted
- 26 Aug 2010
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. 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 Primary NCT00294047 Study
- ClinicalTrials.gov ID
- NCT01190189
- Acronym / sponsor ID
- 113621
- Conditions
- Infections, Papillomavirus
- Keywords
- Serious adverse events (SAEs), HPV vaccine, Medically significant conditions, Cervical neoplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.
Detailed description
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.
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: GSK580299 (Cervarix)Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule. |
Who may qualify
- Ages
- 26 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
- Written informed consent obtained from the subject
- 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 (18 listed)
- Pregnant or breastfeeding.
- A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. 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. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
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 (Cervarix)3-dose schedule intramuscularly vaccination | Biological | Cervarix Group |
Primary outcome
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Month 12)
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: During the entire study period (from Day 0 up to Month 12)
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
Time frame: During the entire study period (from Day 0 up to Month 12)
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
Time frame: During the entire study period (from Day 0 up to Month 12)
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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
28 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 GSK580299 (Cervarix) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 28 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 9 inclusion and 18 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 17 Dec 2018). 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, Grade 3 and Related Serious Adverse Events (SAEs) (time frame: During the entire study period (from Day 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 19 Jun 2019.