Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. 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
NONE
Enrollment
805
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
GSK Investigational Site
Brescia, Lombardy, Italy
GSK Investigational Site
Lodi, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
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 after the third vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titer given as geometric mean titer (GMT).
Time frame: One month after the third vaccine dose
Number of Subjects Seroconverted for Anti-HPV-16 and 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 after the second vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titer given as GMT.
Time frame: One month after the second vaccine dose
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.
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GSK Investigational Site
Cagliari, Sardinia, Italy
GSK Investigational Site
Sassari, Sardinia, Italy
GSK Investigational Site
Palermo, Sicily, Italy
GSK Investigational Site
Ragusa, Sicily, Italy
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Bucharest, Romania
...and 6 more locations
Time frame: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)
Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6. NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses. An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the entire study period (up to Month 18 or up to Month 12)
Number of Subjects With Pregnancies and Their Outcomes
Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6 Number of pregnancies and pregnancy outcomes.
Time frame: During the entire study period (up to Month 18 or Month 12)
Number of Subjects Completing the 3-dose Vaccination Schedule
Time frame: After the third vaccine dose