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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
383
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Golden, Colorado, United States
GSK Investigational Site
Kingston, Rhode Island, 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
Roeselare, Belgium
...and 1 more locations
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 7
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Time frame: At Month 7
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Time frame: At Month 7
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Time frame: At Month 7
Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.
Time frame: At Month 2
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Time frame: At Month 2
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Time frame: At Month 2
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Time frame: At Month 2
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
Time frame: At Month 2 and Month 7
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
Time frame: At Month 2 and Month 7
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Time frame: At Month 2 and Month 7
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Time frame: At Month 2 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.
Time frame: 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
Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time frame: 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)
An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.
Time frame: During the 30-day post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: From Day 0 to Month 7
Number of Subjects With Any SAEs During the Extended Safety Follow-up
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: From Day 0 to Month 12
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
Time frame: From Day 0 to Month 12
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
Time frame: From Day 0 up to Month 12
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
Time frame: From Day 0 up to Month 12
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological \[basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA\]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.
Time frame: At Month 2 and Month 7
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