Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
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|ClinicalTrials.gov Identifier: NCT00492544|
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 21, 2009
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infections, Papillomavirus||Biological: Cervarix™ (HPV-16/18 L1 VLP AS04)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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.
Other Name: 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 [ Time Frame: One month post Dose 3 (Month 7) ]
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.
- Anti-HPV-16 and Anti-HPV-18 Antibody Titers [ Time Frame: Before vaccination (PRE) and one month post Dose 3 (Month 7) ]Titers are given as geometric mean titers (GMTs) calculated on all subjects.
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ]Solicited local symptoms assessed include pain, redness and swelling.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ]Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
- Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 30-day (Days 0-29) period following each vaccination ]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.
- Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions [ Time Frame: From Day 0 up to Month 7 ]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.
- Outcome of All Pregnancies [ Time Frame: Up to Month 7 ]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.
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to Month 7 ]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.
- Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters [ Time Frame: At Day 0 and Month 7 ]
Abnormalities include values outside (above or below) the 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492544
|GSK Investigational Site|
|Saitama, Japan, 360-0812|
|GSK Investigational Site|
|Tokyo, Japan, 136-0073|
|GSK Investigational Site|
|Tokyo, Japan, 154-0024|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|