Infections, PapillomavirusPhase 3NCT00947115

Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

A Phase 3 study testing Blood sampling and Cervico-vaginal secretion (CVS) samples in people with Infections, Papillomavirus, run by GlaxoSmithKline at 6 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

Who is it for?: Ages 20 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: Blood sampling and Cervico-vaginal secretion (CVS) samples
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 525 participants
Where: 6 sitesin 2 countries
Study dates: 22 Sep 2009to 3 Feb 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 20 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 vaccine.
Written informed consent obtained from the subject.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
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 (pharmaceutical product or device).
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00196937 study.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

Germany3 sites

GSK Investigational Site
Berlin, 12200
GSK Investigational Site
Munich, Bavaria, 80637
GSK Investigational Site
Würzburg, Bavaria, 97070

Other trials in Germany

Poland3 sites

GSK Investigational Site
Bydgoszcz, 85-079
GSK Investigational Site
Poznan, 60-535
GSK Investigational Site
Poznan, 61-709

Other trials in Poland

About this study

Official title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives \& outcome measures of the extension phase from Year 5 to Year 10. The objectives \& outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).

Read the detailed description

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Conditions: Infections, Papillomavirus
Being tested: Blood sampling, Cervico-vaginal secretion (CVS) samples
Keywords: Cervical cancer, HPV vaccine
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.

Blood samplingProcedure or surgery
Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.
Cervico-vaginal secretion (CVS) samplesProcedure or surgery
CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Study groups in NCT00947115
Study group	Role	What they receive
Cervarix 15-25 years group	Experimental	Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). Receives: Procedure: Blood sampling; Procedure: Cervico-vaginal secretion (CVS) samples
Cervarix 26-45 years group	Experimental	Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). Receives: Procedure: Blood sampling; Procedure: Cervico-vaginal secretion (CVS) samples
Cervarix 46-55 years group	Experimental	Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). Receives: Procedure: Blood sampling; Procedure: Cervico-vaginal secretion (CVS) samples

What is being measured

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

Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008.
The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.
Measured: At Years 5, 6 and 7
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008.
The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681.
Measured: At Years 8, 9 and 10
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers.
Measured: At Years 5, 6 and 7
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers.
Measured: At Years 8, 9 and 10

Secondary outcomes (15)

Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
Measured: At Year 5 and Year 6
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
Measured: At Years 7, 8, 9 and 10
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
Measured: At Year 5 and Year 6
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
Measured: At Years 7, 8, 9 and 10
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Measured: At Years 5, 6 and 7
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Measured: At Years 8, 9 and 10
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Measured: At Years 5, 6 and 7
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Measured: At Years 8, 9 and 10
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 5 up to Year 6
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 6 up to Year 7
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 7 up to Year 8
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 8 up to Year 9
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 9 up to Year 10
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Measured: From Year 0 up to Year 10

Timeline

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

22 Sep 20093 Feb 2015

First posted27 Jul 2009 (estimated)
Study start22 Sep 2009
Primary completion3 Feb 2015
Study completion3 Feb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00947115
Sponsor's protocol ID: 112772
Other IDs: 2009-011357-41, 2009
Status last verified: Oct 2020
First submitted: 16 Jul 2009
Last updated: 30 Oct 2020
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.

Publications

Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.
PubMed 25208608

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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Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
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All Infections, Papillomavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
ClinicalTrials.gov ID: NCT00947115
Acronym / sponsor ID: 112772
Conditions: Infections, Papillomavirus
Keywords: Cervical cancer, HPV vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 Sep 2009 (actual)
Primary completion: 3 Feb 2015 (actual)
Study completion: 3 Feb 2015 (actual)
First posted: 27 Jul 2009 (estimated)
Results: Posted 2 May 2011

Clinical summary

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

Detailed description

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cervarix 15-25 years group	Experimental	Procedure: Blood sampling, Procedure: Cervico-vaginal secretion (CVS) samplesWomen, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
Cervarix 26-45 years group	Experimental	Procedure: Blood sampling, Procedure: Cervico-vaginal secretion (CVS) samplesWomen, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
Cervarix 46-55 years group	Experimental	Procedure: Blood sampling, Procedure: Cervico-vaginal secretion (CVS) samplesWomen, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Who may qualify

Ages: 20 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 vaccine.
Written informed consent obtained from the subject.

Key exclusion criteria (5 listed)

Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
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 (pharmaceutical product or device).
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00196937 study.

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
Blood samplingBlood samples were collected at Years 5, 6, 7, 8, 9 and 10.	Procedure or surgery	Cervarix 15-25 years group, Cervarix 26-45 years group, Cervarix 46-55 years group
Cervico-vaginal secretion (CVS) samplesCVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.	Procedure or surgery	Cervarix 15-25 years group, Cervarix 26-45 years group, Cervarix 46-55 years group

Primary outcome

Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Time frame: At Years 5, 6 and 7
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Time frame: At Years 8, 9 and 10
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL. The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
Time frame: At Years 5, 6 and 7
Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
Time frame: At Years 8, 9 and 10
Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers.

15 secondary outcomes

Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Time frame: At Year 5 and Year 6
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Time frame: At Years 7, 8, 9 and 10
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
Time frame: At Year 5 and Year 6
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
Time frame: At Years 7, 8, 9 and 10
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
Time frame: At Years 5, 6 and 7
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
Time frame: At Years 8, 9 and 10
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
Time frame: At Years 5, 6 and 7
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
Time frame: At Years 8, 9 and 10
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
Time frame: From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
Time frame: From Year 5 up to Year 6
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
Time frame: From Year 6 up to Year 7
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
Time frame: From Year 7 up to Year 8
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
Time frame: From Year 8 up to Year 9
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
Time frame: From Year 9 up to Year 10
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
Time frame: From Year 0 up to Year 10

Results and safety

Results posted to the registry on 2 May 2011, 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 15-25 Years Group	159	142
Cervarix 26-45 Years Group	194	172
Cervarix 46-55 Years Group	171	156

Primary outcome: Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7

Time frame: At Years 5, 6 and 7. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Cervarix 15-25 Years Group n = 134	Cervarix 26-45 Years Group n = 146	Cervarix 46-55 Years Group n = 146
Anti-HPV-16 [Year 5]	1495.7 (1249.2 to 1790.9)	518.7 (423.2 to 635.6)	282.4 (234.3 to 340.5)
Anti-HPV-16 [Year 6]	1344.6 (1130.2 to 1599.6)	526.0 (434.7 to 636.4)	277.7 (228.0 to 338.2)
Anti-HPV-16 [Year 7]	1014.0 (847.0 to 1214.0)	369.5 (295.7 to 461.7)	201.4 (163.6 to 247.9)
Anti-HPV-18 [Year 5]	440.4 (367.8 to 527.2)	168.8 (140.7 to 202.4)	104.6 (86.0 to 127.2)
Anti-HPV-18 [Year 6]	438.2 (366.6 to 523.7)	167.5 (138.1 to 203.1)	97.6 (79.2 to 120.3)
Anti-HPV-18 [Year 7]	307.8 (256.2 to 369.7)	119.8 (98.4 to 145.9)	81.7 (65.7 to 101.5)

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available.

Primary outcome: Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10

Time frame: At Years 8, 9 and 10. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Cervarix 15-25 Years Group n = 132	Cervarix 26-45 Years Group n = 148	Cervarix 46-55 Years Group n = 132
Anti-HPV-16 [Year 8]	1123.3 (930.2 to 1356.5)	392.1 (315.3 to 487.7)	189.1 (153.0 to 233.7)
Anti-HPV-16 [Year 9]	980.9 (825.5 to 1165.6)	366.5 (303.5 to 442.6)	180.2 (148.4 to 218.7)
Anti-HPV-16 [Year 10]	965.4 (802.2 to 1161.8)	334.4 (270.5 to 413.5)	157.4 (128.4 to 193.1)
Anti-HPV-18 [Year 8]	375.1 (310.6 to 453.0)	134.1 (107.5 to 167.4)	82.6 (65.9 to 103.6)
Anti-HPV-18 [Year 9]	327.4 (273.4 to 392.1)	122.5 (101.1 to 148.4)	75.6 (60.9 to 94.0)
Anti-HPV-18 [Year 10]	321.1 (265.0 to 389.1)	115.4 (93.9 to 142.0)	69.7 (56.0 to 86.8)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 8, 9 and 10 were available.

Primary outcome: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7

Time frame: At Years 5, 6 and 7. Count of participants. Unit: Participants

Measure	Cervarix 15-25 Years Group n = 134	Cervarix 26-45 Years Group n = 146	Cervarix 46-55 Years Group n = 146
anti-HPV-16 [Year 5]	128	127	118
anti-HPV-16 [Year 6]	128	130	116
anti-HPV-16 [Year 7]	125	119	111
anti-HPV-18 [Year 5]	134	144	143
anti-HPV-18 [Year 6]	133	146	138
anti-HPV-18 [Year 7]	130	135	131

Population analysed: The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available.

Primary outcome: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10

Time frame: At Years 8, 9 and 10. Count of participants. Unit: Participants

Measure	Cervarix 15-25 Years Group n = 132	Cervarix 26-45 Years Group n = 148	Cervarix 46-55 Years Group n = 132
anti-HPV-16 [Year 8]	116	106	95
anti-HPV-16 [Year 9]	127	132	106
anti-HPV-16 [Year 10]	123	120	103
anti-HPV-18 [Year 8]	120	118	104
anti-HPV-18 [Year 9]	132	141	113
anti-HPV-18 [Year 10]	126	133	109

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: Throughout the entire study period (from Year 0 up to the Year 10).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix 15-25 Years Group	0 of 159 (0%)	0 of 0	0 of 159
Cervarix 26-45 Years Group	2 of 194 (1%)	0 of 0	1 of 194
Cervarix 46-55 Years Group	1 of 171 (0.6%)	0 of 0	1 of 171

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25208608Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.
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

6 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 Blood sampling and Cervico-vaginal secretion (CVS) samples in people with Infections, Papillomavirus, run by GlaxoSmithKline at 6 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 3 inclusion and 5 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 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Poland. 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 2 May 2011). 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?

Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 (time frame: At Years 5, 6 and 7). 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?

On the ClinicalTrials.gov record for NCT00947115, which also lists 1 linked publication.

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 2020.