Last updated: 11/26/2019 12:11:50
Human Papilloma virus vaccine immunogenicity and safety trial in young adult women with GSK Bio's novel HPV vaccine.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A dose-range study to assess the safety and immunogenicity of a novel HPV vaccine when administered intramuscularly according to a 3-dose schedule (0,1,6-month) in healthy adult females (18-25 years of age)
Trial description: Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of seroconverted subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Timeframe: At Month 7
Number of seroconverted subjects for Anti-HPV-18 at Month 7
Timeframe: At Month 7
Anti-HPV-16 antibody titers assessed by ELISA at Month 7
Timeframe: At Month 7
Anti-HPV-18 antibody titers assessed by ELISA at Month 7
Timeframe: At Month 7
Secondary outcomes:
Number of seroconverted subjects for Anti-HPV-16 at Month 2
Timeframe: At Month 2
Number of seroconverted subjects for Anti-HPV-18 at Month 2
Timeframe: At Month 2
Anti-HPV-16 antibody titers assessed by ELISA at Month 2
Timeframe: At Month 2
Anti-HPV-18 antibody titers assessed by ELISA at Month 2
Timeframe: At Month 2
Number of seroconverted subjects for Anti-HPV-31 at Months 2 and 7
Timeframe: At Month 2 and Month 7
Number of seroconverted subjects for Anti-HPV-45 at Months 2 and 7
Timeframe: At Month 2 and Month 7
Anti-HPV-31 antibody titers assessed by ELISA at Months 2 and 7
Timeframe: At Month 2 and Month 7
Anti-HPV-45 antibody titers assessed by ELISA at Months 2 and 7
Timeframe: At Month 2 and Month 7
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: During the 7 day post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 7 day post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 30-day post-vaccination period
Number of subjects with any serious adverse events (SAEs)
Timeframe: From Day 0 to Month 7
Number of subjects with any SAEs during the extended safety follow-up
Timeframe: From Day 0 to Month 12
Number of subjects reporting pregnancies and outcomes of reported pregnancies
Timeframe: From Day 0 to Month 12
Number of subjects reporting New Onset of Chronic Diseases (NOCDs)
Timeframe: From Day 0 up to Month 12
Number of subjects reporting medically significant conditions
Timeframe: From Day 0 up to Month 12
Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters
Timeframe: At Month 2 and Month 7
Interventions:
Biological/vaccine: HPV 16/18 L1 AS04
Biological/vaccine: HPV-16/18/31/45 L1 AS04 Formulation 1
Biological/vaccine: HPV-16/18/31/45 L1 AS04 Formulation 2
Biological/vaccine: HPV-16/18/31/45 L1 AS04 Formulation 3
Biological/vaccine: HPV-16/18/31/45 L1 AS04 Formulation 4
Biological/vaccine: HPV-16/18/31/45 L1 AS04 Formulation 5
Biological/vaccine: HPV-16/18/31/45 L1 AS04 Formulation 6
Enrollment:
383
Observational study model:
Not applicable
Primary completion date:
2006-27-03
Time perspective:
Not applicable
Clinical publications:
Van Damme P et al. (2014) Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 32(29):3694-3705.
Medical condition
Infections, Papillomavirus
Product
GSK568893A, SB580299
Collaborators
Not applicable
Study date(s)
March 2005 to March 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 25 Years
Accepts healthy volunteers
Yes
- A woman between, and including, 18 and 25 years of age at the time of the first vaccination
- Written informed consent from the subject prior to enrolment
- Pregnant or breastfeeding
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
Inclusion and exclusion criteria
Inclusion criteria:
- A woman between, and including, 18 and 25 years of age at the time of the first vaccination
- Written informed consent from the subject prior to enrolment
- Subject must be free of obvious health problems
- Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners
Exclusion criteria:
- Pregnant or breastfeeding
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
- History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
- Previous vaccination against human papillomavirus (HPV)
Trial location(s)
Location
GSK Investigational Site
Aurora, Colorado, United States, 80045
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Kingston, Rhode Island, United States, 02881
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
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
2006-27-03
Actual study completion date
2006-27-03
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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