Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
152
Intramuscular administration, 3 doses.
Intramuscular administration, 4 doses.
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
La Louvière, Belgium
Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix
A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).
Time frame: Month 3
Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix
Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).
Time frame: Month 3
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 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: Months 2 and 7
Anti-HPV-16/18 Antibody Titers
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: Months 2 and 7
Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies
Anti-HBs seroconversion is defined as the appearance \[i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)\] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.
Time frame: Months 2, 3 and 13
Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course
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A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.
Time frame: Months 2 and 13
Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
Time frame: At Months 2 and 13
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
Time frame: During the 7-day period following any vaccination
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
Time frame: During the 7-day period following the 4th dose of HBV vaccine
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \[axillary route, ≥ 37.5 degree Celsius (°C)\] and urticaria. Data are presented across doses.
Time frame: During the 7-day period following any vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \[axillary route, ≥ 37.5 degree Celsius (°C)\] and urticaria. Data are presented across doses.
Time frame: During the 7-day period following the 4th dose of HBV vaccine
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period following any vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period following the 4th dose of HBV vaccine
Number of Subjects Reporting Serious Adverse Events (SAE)
SAEs 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: Up to study end (Month 13)
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up to study end (Month 13)