Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine. 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
DOUBLE
Enrollment
225
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
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 Titres
Titres are given as geometric mean titres (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 at the injection site.
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 Medically Significant Conditions
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GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.
Time frame: From Day 0 up to Month 7
Number of Subjects Reporting Serious Adverse Events (SAE)
Serious adverse events assessed include medical occurrences that result in death, is 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 With Pregnancies and Their Outcome
Total: the total number of pregnancies in a group. The specific outcomes are also listed.
Time frame: from Day 0 up to Month 7