Last updated: 07/17/2024 15:13:06
Human papillomavirus vaccine immunogenicity and safety trial in young adult women with GSK Biologicals novel HPV vaccine
GSK study ID
108052 (FU month 18)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A long-term, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ novel HPV vaccine in healthy female subjects vaccinated in the primary study
Trial description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological’s has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological’s vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroconverted subjects against Human papillomavirus-16 (HPV-16) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Geometric mean titers (GMTs) for Human papillomavirus-16 (HPV-16) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Geometric mean titers (GMTs) for Human papillomavirus-16 (HPV-16) antibodies
Timeframe: At Months 18, 24, 36 and 48.
Number of seroconverted subjects against Human papillomavirus-18 (HPV-18) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Geometric mean titers (GMTs) for Human papillomavirus-18 (HPV-18) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Geometric mean titers (GMTs) for Human papillomavirus-18 (HPV-18) antibodies
Timeframe: At Months 18, 24, 36 and 48.
Secondary outcomes:
Number of seroconverted subjects against Human papillomavirus-31 (HPV-31) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Geometric mean titers (GMTs) for Human papillomavirus-31 (HPV-31) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Number of seroconverted subjects against Human papillomavirus-45 (HPV-45) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Geometric mean titers (GMTs) for Human papillomavirus-45 (HPV-45) antibodies.
Timeframe: At Months 18, 24, 36 and 48.
Number of subjects with at least one New Onset of Chronic Disease (NOCDs)
Timeframe: From Month 0 to Months 18, 24, 36 and 48
Number of subjects with at least one medically significant condition (MAEs).
Timeframe: From Month 0 to Months 18, 24, 36 and 48
Number of subjects with any serious adverse events (SAEs).
Timeframe: From Month 0 to Months 18, 24, 36 and 48
Number of subjects with pregnancy outcomes.
Timeframe: From Month 0 to Month 18
Number of subjects with pregnancy outcomes.
Timeframe: From Month 0 to Month 24
Number of subjects with pregnancy outcomes.
Timeframe: From Month 0 to Month 36
Number of subjects with pregnancy outcomes.
Timeframe: From Month 0 to Month 48
Interventions:
Biological/vaccine: CervarixTM
Biological/vaccine: HPV investigational vaccine GSK568893A, different formulations
Enrollment:
383
Observational study model:
Not applicable
Primary completion date:
2007-30-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus
Product
GSK568893A, SB580299
Collaborators
Not applicable
Study date(s)
September 2006 to January 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 25 years
Accepts healthy volunteers
Yes
- A female who enrolled in the study 102115 and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment.
- Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
Inclusion and exclusion criteria
Inclusion criteria:
- A female who enrolled in the study 102115 and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment.
Exclusion criteria:
- Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.
Trial location(s)
Location
GSK Investigational Site
Denver, Colorado, United States, 80262
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-30-01
Actual study completion date
2007-30-01
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website