immunogenicity and safety study of gsk biologicals' human papillomavirus 580299 vaccine in healthy female subjects

Conditions: Infections, Papillomavirus

Summary: this study is designed to evaluate the immunogenicity and safety of glaxosmithkline biologicals' human papillomavirus (hpv) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. one group of subjects will receive the hpv vaccine and the other group will receive the control.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they or their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol. * healthy chinese females between and including 9 and 17 years of age at the time of the first vaccination. * written informed consent obtained from the parent(s)/lar(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment. * healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * subjects must not be pregnant. absence of pregnancy will be verified with a urine pregnancy test before each vaccination. * subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., days 0-29) the first dose of vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * a subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * pregnant or breastfeeding. subjects must be at least three months post-pregnancy and not breastfeeding to enter the study. * previous vaccination against hpv or planned administration of any hpv vaccine other than that foreseen by the protocol during the study period. * previous administration of components of the study vaccine. * history of chronic condition(s) requiring treatment such as cancer or autoimmune disease. * history of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine. * hypersensitivity to latex. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Keywords: immunogenicity safety human papillomavirus china hpv vaccine