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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
383
Subjects were administered three doses of HPV vaccine
Subjects were administered three doses of HPV investigational vaccine
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Golden, Colorado, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Liège, Belgium
GSK Investigational Site
Tienen, Belgium
GSK Investigational Site
Wilrijk, Belgium
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
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Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Any 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. Any = Occurrence of any symptom regardless of intensity grade.
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
Time frame: From Month 0 to Month 18
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
Time frame: From Month 0 to Month 24
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
Time frame: From Month 0 to Month 36
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
Time frame: From Month 0 to Month 48