Infections, PapillomavirusPhase 3NCT01190176

Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

A Phase 3 study testing Gynaecological follow-up and Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 20 sites in 7 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 study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit. Read more about this study

Who is it for?: Ages 28 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: Gynaecological follow-up and Cervarix
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 20 sitesin 7 countries
Study dates: 12 Sep 2011to 20 Sep 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 28 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Written informed consent obtained from the subject prior to enrolment.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:
displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding NCT00294047 study visit
was pregnant so that no cervical sample could be collected at her concluding NCT00294047 study visit

Who cannot join

A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.

Trial locations and contacts

20 sites in 7 countries.

Country

City, postcode or hospital

20 sites in 7 countries

Canada5 sites

GSK Investigational Site
Edmonton, Alberta, T6G 2C8
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Vancouver, British Columbia, V6H 3N1

Other trials in Canada

Portugal4 sites

GSK Investigational Site
Almada, 2805-267 Almada
GSK Investigational Site
Coimbra, 3000-075 Coimbra
GSK Investigational Site
Lisbon, 1200-831 Lisboa
GSK Investigational Site
Setúbal, 2910-446 Setúbal

Other trials in Portugal

United States3 sites

GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Netherlands2 sites

GSK Investigational Site
Amsterdam, 1007 MB
GSK Investigational Site
Rotterdam, 3015 CE

Other trials in Netherlands

Russia2 sites

GSK Investigational Site
Moscow, 109263
GSK Investigational Site
Saint Petersburg, 199034

Other trials in Russia

Singapore2 sites

GSK Investigational Site
Singapore, 119074
GSK Investigational Site
Singapore, 229899

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United Kingdom2 sites

GSK Investigational Site
London, E1 1BB
GSK Investigational Site
Manchester, M13 9WL

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About this study

Official title: Gynaecological Follow-up of a Subset of HPV-015 Study Subjects

Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit.

The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

Read the detailed description

Cervarix or Control [Al(OH)3] has been administered in the primary study NCT00294047.

Conditions: Infections, Papillomavirus
Being tested: Gynaecological follow-up, Cervarix, Placebo control
Keywords: HPV, HPV vaccine, Cervical neoplasia, Human papillomavirus, Papillomavirus, Cervical cancer, Human papillomavirus (HPV) type 16/18 infections
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.

Gynaecological follow-upProcedure or surgery
Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.
CervarixBiological
Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
Placebo controlBiological
Subjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Study groups in NCT01190176
Study group	Role	What they receive
HPV-062 study subjects Group	Experimental	HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit. Receives: Procedure: Gynaecological follow-up; Biological: Cervarix; Biological: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Measured: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Measured: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Measured: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Measured: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Measured: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Measured: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Measured: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).
Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Measured: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Colposcopy at Month 12
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Measured: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Colposcopy at Month 24
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Measured: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Colposcopy at Month 36
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Measured: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Colposcopy at Month 48
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Measured: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Treatment at Month 12
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Measured: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Treatment at Month 24
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Measured: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Treatment at Month 36
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Measured: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of Subjects With Referral to Treatment at Month 48
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Measured: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 201120 Sep 2017

First posted27 Aug 2010 (estimated)
Study start12 Sep 2011
Primary completion20 Sep 2017
Study completion20 Sep 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: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190176
Sponsor's protocol ID: 113617
Other IDs: 2009-017282-35, 2009
Status last verified: Oct 2019
First submitted: 26 Aug 2010
Last updated: 30 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD for this study is 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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Human Papillomavirus Infection
Active, not recruitingPhase 4
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Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
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All Infections, Papillomavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
ClinicalTrials.gov ID: NCT01190176
Acronym / sponsor ID: 113617
Conditions: Infections, Papillomavirus
Keywords: HPV, HPV vaccine, Cervical neoplasia, Human papillomavirus, Papillomavirus, Cervical cancer, Human papillomavirus (HPV) type 16/18 infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 12 Sep 2011 (actual)
Primary completion: 20 Sep 2017 (actual)
Study completion: 20 Sep 2017 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 17 Oct 2018

Clinical summary

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

Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit.

The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

Detailed description

Cervarix or Control [Al(OH)3] has been administered in the primary study NCT00294047.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HPV-062 study subjects Group	Experimental	Procedure: Gynaecological follow-up, Biological: Cervarix, Biological: Placebo controlHPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.

Who may qualify

Ages: 28 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Written informed consent obtained from the subject prior to enrolment.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:

Key exclusion criteria (3 listed)

A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.

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
Gynaecological follow-upSubjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.	Procedure or surgery	HPV-062 study subjects Group
CervarixSubjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.	Biological	HPV-062 study subjects Group
Placebo controlSubjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.	Biological	HPV-062 study subjects Group

Primary outcome

Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
Time frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24
Time frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36
Time frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48
Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
Time frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
Time frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
Time frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
Number of Subjects With Referral to Colposcopy at Month 12
Time frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Number of Subjects With Referral to Colposcopy at Month 24
Time frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Number of Subjects With Referral to Colposcopy at Month 36
Time frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Number of Subjects With Referral to Colposcopy at Month 48
Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Number of Subjects With Referral to Treatment at Month 12
Time frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Number of Subjects With Referral to Treatment at Month 24
Time frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Number of Subjects With Referral to Treatment at Month 36
Time frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.
Number of Subjects With Referral to Treatment at Month 48
Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.

Results and safety

Results posted to the registry on 17 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HPV-062 Study Subjects Group	32	30

Primary outcome: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12

Time frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]. Count of participants. Unit: Participants

Measure	HPV-062 Study Subjects Group n = 13
Value	2

Population analysed: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.

Primary outcome: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24

Time frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]. Count of participants. Unit: Participants

Measure	HPV-062 Study Subjects Group n = 12
Value	3

Primary outcome: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36

Time frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]. Count of participants. Unit: Participants

Measure	HPV-062 Study Subjects Group n = 9
Value	3

Primary outcome: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48

Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]. Count of participants. Unit: Participants

Measure	HPV-062 Study Subjects Group n = 6
Value	1

Adverse events

Time frame: Adverse events (AEs) and serious adverse events (SAEs): During the entire study period [from 12 months after concluding HPV-015 (NCT00294047) study visit (Visit 9/Visit 11/Last visit) up to 48 months after concluding HPV-015 (NCT00294047) study visit (Visit 9/Visit 11/Last visit)].. Other adverse events reported at 0.0001% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HPV-062 Study Subjects Group	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study is 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

20 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gynaecological follow-up and Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 20 sites in 7 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 5 inclusion and 3 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Canada, Portugal, United States, Netherlands, Russia and 2 more countries. 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 Oct 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 Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12 (time frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]). The study lists 16 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 NCT01190176.

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 30 Oct 2019.