Infections, PapillomavirusPhase 3NCT00877877
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
A Phase 3 study testing Blood sampling in people with Infections, Papillomavirus and Papillomavirus Vaccines, run by GlaxoSmithKline at 26 sites in 5 countries.
Trial summary
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 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the… Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus, Papillomavirus Vaccines
- What is being tested?
- Blood sampling
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 7 May 2009to 6 Jan 2015
- Phase
- Phase 3
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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
- A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
- Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.
Who cannot join
- 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.
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
- Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
Germany20 sites
GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 10967
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Hamburg, 22307
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18109
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Weilheim, Bavaria, 82362
GSK Investigational Site
Weimar, Thuringia, 99423
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Würzburg, Bavaria, 97070
Panama2 sites
GSK Investigational Site
Arraijan/Vista Alegre, Provincia de Panamá
GSK Investigational Site
La Chorrera
Taiwan2 sites
GSK Investigational Site
Taipei, 10002
GSK Investigational Site
Taoyuan, 333
Honduras1 site
GSK Investigational Site
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) 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 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Read the detailed description
Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be 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.
- Being tested
- Blood sampling
- Keywords
- HPV vaccine, cervical cancer
- 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 to be collected at Months 60, 72, 84, 96, 108 and 120
| Study group | Role | What they receive |
|---|---|---|
| Cervarix Group | Other | Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule. Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 60
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 72
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 84
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 96
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Measured: At Month 60
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Measured: At month 72
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Measured: At Month 84
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Measured: At Month 96
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 108
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Measured: At Month 108
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 120
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Measured: At Month 120
Secondary outcomes (6)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 48 to Month 60
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 60 to Month 72
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 72 to Month 84
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 84 to Month 96
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 96 to Month 108
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Month 108 to Month 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study start7 May 2009
- Primary completion6 Jan 2015
- Study completion6 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 632 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
- NCT00877877
- Sponsor's protocol ID
- 111375
- Other IDs
- 2008-000369-44, 2008
- Status last verified
- Dec 2019
- First submitted
- 26 Mar 2009
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460.
PubMed 24978856Schwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17.
PubMed 31268383