Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,067
GSK Investigational Site
North Adelaide, South Australia, Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.
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Pardubice, Czechia
GSK Investigational Site
Aubevoye, France
GSK Investigational Site
Broglie, France
GSK Investigational Site
Évreux, France
GSK Investigational Site
Luynes, France
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