The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV vaccine according to 0, 6 month schedule, compared to the administration of either of these vaccines alone. The study will ascertain that the immune responses elicited to the two vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV vaccine are administered alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Time frame: One month after the second dose (Month 7)
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Time frame: One month after the second dose (Month 7)
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Time frame: One month after the second dose (Month 7)
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Time frame: One month after the second dose (Month 7)
Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Time frame: One month after the second dose (Month 7)
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group
Time frame: One month after the second dose (Month 7)
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group
Time frame: One month after the second dose (Month 7)
Anti-HAV antibody titres in the HPV+HAV group and the HAV group
Time frame: One month after the second dose (Month 7)
Occurrence of any and Grade 3 solicited local symptoms (injection site pain, redness and swelling) in all study groups
Time frame: During the 7-day period (Day 0-6) following each vaccination
Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups
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Time frame: During the 7-day period (Day 0-6) following each vaccination
Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs in all study groups
Time frame: During the 30-day period (Day 0-29) following any vaccination
Occurrence of any and causally related to vaccination serious adverse events (SAEs) in all groups
Time frame: Throughout the active phase of the study (up to Month 7) and during the extended safety follow-up period (up to Month 12)
Occurrence of medically significant conditions (MSCs) in all groups
Time frame: Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)
Occurrence of potential immune-mediated diseases (pIMDs) in all groups
Time frame: Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)
Occurrence of pregnancies and pregnancy outcomes
Time frame: During the entire study period (Month 0 - Month 12)