Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
- Conditions
- Infections, Papillomavirus
- Interventions
- Biological: HPV-16/18/31/45 L1 AS04 Formulation 3Biological: HPV-16/18/31/45 L1 AS04 Formulation 4Biological: HPV-16/18/31/45 L1 AS04 Formulation 6Biological: HPV 16/18 L1 AS04Biological: HPV-16/18/31/45 L1 AS04 Formulation 1Biological: HPV-16/18/31/45 L1 AS04 Formulation 2Biological: HPV-16/18/31/45 L1 AS04 Formulation 5
- Registration Number
- NCT00231413
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 383
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HPV-TETRA C Group HPV-16/18/31/45 L1 AS04 Formulation 3 Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. HPV-TETRA D Group HPV-16/18/31/45 L1 AS04 Formulation 4 Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. HPV-TETRA F Group HPV-16/18/31/45 L1 AS04 Formulation 6 Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. HPV-16/18 Group HPV 16/18 L1 AS04 Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. HPV-TETRA A Group HPV-16/18/31/45 L1 AS04 Formulation 1 Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. HPV-TETRA B Group HPV-16/18/31/45 L1 AS04 Formulation 2 Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. HPV-TETRA E Group HPV-16/18/31/45 L1 AS04 Formulation 5 Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
- Primary Outcome Measures
Name Time Method Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 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).
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7 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.
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7 At Month 7 Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7 At Month 7 Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
- Secondary Outcome Measures
Name Time Method Number of Seroconverted Subjects for Anti-HPV-16 at Month 2 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.
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2 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.
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2 At Month 2 Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2 At Month 2 Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7 At Month 2 and Month 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.
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7 At Month 2 and Month 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.
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7 At Month 2 and Month 7 Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7 At Month 2 and Month 7 Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the 7 day post-vaccination period following each dose and across doses 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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the 7 day post-vaccination period following each dose and across doses 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) During the 30-day post-vaccination period 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.
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 0 to Month 7 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.
Number of Subjects With Any SAEs During the Extended Safety Follow-up From Day 0 to Month 12 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.
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies From Day 0 to Month 12 Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) From Day 0 up to Month 12 NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
Number of Subjects Reporting Medically Significant Conditions From Day 0 up to Month 12 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.
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters At Month 2 and Month 7 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇧🇪Wilrijk, Belgium