A Phase 3 interventional study of Cervarix™ (HPV-16/18 L1 VLP AS04) in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 5 sites in Japan. Open to female participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-04.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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Exclusion Criteria:
Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Biological: Cervarix™ (HPV-16/18 L1 VLP AS04)
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Also known as: GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time frame: One month post Dose 3 (Month 7)
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Time frame: Before vaccination (PRE) and one month post Dose 3 (Month 7)
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time frame: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Unsolicited adverse event= Any adverse event (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.
Time frame: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.
Time frame: From Day 0 up to Month 7
Outcome of All Pregnancies
According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.
Time frame: Up to Month 7
Number of Subjects Reporting Serious Adverse Events (SAEs)
Serious adverse events 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.
Time frame: From Day 0 up to Month 7
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Abnormalities include values outside (above or below) the normal ranges. Normal ranges: alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL
Time frame: At Day 0 and Month 7
| Milestone | Cervarix Group |
|---|---|
| Started | 100 |
| Completed | 100 |
| Not completed | 0 |
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
| Participants | Cervarix Group |
|---|---|
| Anti-HPV-16 | 92 |
| Anti-HPV-18 | 94 |
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
| titer | Cervarix Group |
|---|---|
| Anti-HPV-16 (PRE) | 4.4 (4.1 to 4.8) |
| Anti-HPV-16 (Month 7) | 19748.0 (17147.7 to 22742.7) |
| Anti-HPV-18 (PRE) | 3.7 (3.5 to 3.9) |
| Anti-HPV-18 (Month 7) | 8765.3 (7543.8 to 10184.4) |
Solicited local symptoms assessed include pain, redness and swelling.
| Participants | Cervarix Group |
|---|---|
| Pain | 98 |
| Redness | 85 |
| Swelling | 81 |
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
| Participants | Cervarix Group |
|---|---|
| Arthralgia | 15 |
| Fatigue | 40 |
| Fever | 10 |
| Gastrointestinal symptoms | 17 |
| Headache | 33 |
| Myalgia | 26 |
| Rash | 5 |
| Urticaria | 3 |
Unsolicited adverse event= Any adverse event (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.
| Participants | Cervarix Group |
|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | 63 |
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.
| Participants | Cervarix Group |
|---|---|
| NOCDs | 0 |
| Medically significant conditions | 18 |
According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.
No measurements were reported for this outcome.
Serious adverse events 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.
| Participants | Cervarix Group |
|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 |
Abnormalities include values outside (above or below) the normal ranges. Normal ranges: alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL
| Participants | Cervarix Group |
|---|---|
| ALT Above (Day 0) | 2 |
| ALT Below (Day 0) | 0 |
| ALT Above (Month 7) | 1 |
| ALT Below (Month 7) | 0 |
| AST Above (Day 0) | 0 |
| AST Below (Day 0) | 0 |
| AST Above (Month 7) | 1 |
| AST Below (Month 7) | 0 |
| Basophils Above (Day 0) | 0 |
| Basophils Below (Day 0) | 0 |
| Basophils Above (Month 7) | 0 |
| Basophils Below (Month 7) | 0 |
| Blood urea nitrogen Above (Day 0) | 2 |
| Blood urea nitrogen Below (Day 0) | 0 |
| Blood urea nitrogen Above (Month 7) | 0 |
| Blood urea nitrogen Below (Month 7) | 0 |
| Creatinine Above (Day 0) | 0 |
| Creatinine Below (Day 0) | 0 |
| Creatinine Above (Month 7) | 0 |
| Creatinine Below (Month 7) | 0 |
| Eosinophils Above (Day 0) | 17 |
| Eosinophils Below (Day 0) | 0 |
| Eosinophils Above (Month 7) | 8 |
| Eosinophils Below (Month 7) | 0 |
| Hematocrit Above (Day 0) | 2 |
| Hematocrit Below (Day 0) | 0 |
| Hematocrit Above (Month 7) | 0 |
| Hematocrit Below (Month 7) | 1 |
| Hemoglobin Above (Day 0) | 0 |
| Hemoglobin Below (Day 0) | 0 |
| Hemoglobin Above (Month 7) | 1 |
| Hemoglobin Below (Month 7) | 1 |
| Lymphocytes Above (Day 0) | 13 |
| Lymphocytes Below (Day 0) | 0 |
| Lymphocytes Above (Month 7) | 4 |
| Lymphocytes Below (Month 7) | 0 |
| Monocytes Above (Day 0) | 1 |
| Monocytes Below (Day 0) | 0 |
| Monocytes Above (Month 7) | 13 |
| Monocytes Below (Month 7) | 0 |
| Neutrophils Above (Day 0) | 0 |
| Neutrophils Below (Day 0) | 21 |
| Neutrophils Above (Month 7) | 0 |
| Neutrophils Below (Month 7) | 7 |
| Platelets Above (Day 0) | 0 |
| Platelets Below (Day 0) | 0 |
| Platelets Above (Month 7) | 0 |
| Platelets Below (Month 7) | 0 |
| Red blood cells Above (Day 0) | 0 |
| Red blood cells Below (Day 0) | 1 |
| Red blood cells Above (Month 7) | 0 |
| Red blood cells Below (Month 7) | 0 |
| Total protein Above (Day 0) | 0 |
| Total protein Below (Day 0) | 8 |
| Total protein Above (Month 7) | 0 |
| Total protein Below (Month 7) | 3 |
| Total bilirubin Above (Day 0) | 2 |
| Total bilirubin Below (Day 0) | 0 |
| Total bilirubin Above (Month 7) | 4 |
| Total bilirubin Below (Month 7) | 0 |
| White blood cells Above (Day 0) | 0 |
| White blood cells Below (Day 0) | 1 |
| White blood cells Above (Month 7) | 0 |
| White blood cells Below (Month 7) | 5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix Group | — | 0/100 (0%) | 100/100 (100%) |
| Event | Cervarix Group |
|---|---|
| PainGeneral disorders | 98/100 |
| RednessGeneral disorders | 85/100 |
| SwellingGeneral disorders | 81/100 |
| FatigueGeneral disorders | 40/100 |
| HeadacheGeneral disorders | 33/100 |
| MyalgiaGeneral disorders | 26/100 |
| NasopharyngitisInfections and infestations | 18/100 |
| Gastrointestinal symptomsGeneral disorders | 17/100 |
| Injection site pruritusGeneral disorders | 16/100 |
| ArthralgiaGeneral disorders | 15/100 |
| Age, Continuous(years) | Cervarix Group |
|---|---|
| Mean | 12.1 ± 1.60 |
| Sex: Female, Male(Participants) | Cervarix Group |
|---|---|
| Female | 100 |
| Male | 0 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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