This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,245
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Deggingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Weilheim, Bavaria, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Hamburg, Hamburg, Germany
...and 18 more locations
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: At 18, 24, 36 and 48 months
Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time frame: At Months 18 and 24
Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time frame: At Month 36 and 48
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up
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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.
Time frame: From Month 18 to Month 24
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up
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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.
Time frame: From Month 24 to Month 48
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