Last updated: 07/17/2024 15:18:10
Evaluation of long-term immunogenicity and safety of a Human Papillomavirus (HPV) vaccine in healthy female subjects.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Follow-up study to evaluate the long-term immunogenicity and safety of a HPV vaccine (GSK 580299) in healthy female subjects
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of seroconverted subjects with anti-HPV-16/18 antibody titers equal to or above cut-off values.
Timeframe: At Month 60
Number of seroconverted subjects with anti-HPV-16/18 antibody titers equal to or above cut-off values.
Timeframe: At Month 72
Number of seroconverted subjects with anti-HPV-16/18 antibody titers equal to or above cut-off values.
Timeframe: At Month 84
Number of seroconverted subjects with anti-HPV-16/18 antibody titers equal to or above cut-off values.
Timeframe: At Month 96
Anti-human papillomavirus-16 and 18 (anti-HPV-16/18) antibody titers
Timeframe: At Month 60
Anti-human papillomavirus-16 and 18 (anti-HPV-16/18) antibody titers
Timeframe: At month 72
Anti-human papillomavirus-16 and 18 (anti-HPV-16/18) antibody titers
Timeframe: At Month 84
Anti-human papillomavirus-16 and 18 (anti-HPV-16/18) antibody titers
Timeframe: At Month 96
Number of seroconverted subjects with anti-HPV-16/18 antibody titers equal to or above cut-off values.
Timeframe: At Month 108
Anti-human papillomavirus-16 and 18 (anti-HPV-16/18) antibody titers
Timeframe: At Month 108
Anti-human papillomavirus-16 and 18 (anti-HPV-16/18) antibody titers
Timeframe: At Month 120
Number of seroconverted subjects with anti-HPV-16/18 antibody titers equal to or above cut-off values.
Timeframe: At Month 120
Secondary outcomes:
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 48 to Month 60
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 60 to Month 72
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 72 to Month 84
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 84 to Month 96
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 96 to Month 108
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 108 to Month 120
Interventions:
Procedure/surgery: Blood sampling
Enrollment:
632
Observational study model:
Not applicable
Primary completion date:
2015-06-01
Time perspective:
Not applicable
Clinical publications:
Schwarz TF et al. (2014) 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. 33(12):1255-1261.
Schwarz TF et al. (2019) 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. 15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
May 2009 to January 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
15 - 24 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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 location(s)
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Status
Study Complete
Location
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Harrislee, Schleswig-Holstein, Germany, 24955
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
La Chorrera, Panamá, Panama, NOT AVAILABLE
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Tegucigalpa, Francisco Morazan, Honduras, 11101
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-06-01
Actual study completion date
2015-06-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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