Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule
Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule
The purpose of this study is to assess the occurrence of serious adverse events (SAEs) as
 well as evaluate the occurrence of solicited local and solicited general symptoms and the
 occurrence of medically significant conditions reported throughout the study period.
Inclusion Criteria:

 -  Subjects who the investigator believes that they can and will comply with the
 requirements of the protocol (e.g., completion of the diary cards, return for
 vaccination visits and for the follow-up visit) should be enrolled in the study.

 • The female subject should be:

 -  married

 -  of Vietnamese origin, residing in Vietnam, and

 -  between, and including, 25 to 40 years of age at the time of the first vaccination.

 -  Written informed consent obtained from the subject (prior to enrolment).

 -  Healthy subjects as established by medical history and clinical examination
 before entering into the study.

 -  Subjects must have a negative urine pregnancy test.

 -  Subjects of childbearing potential (i.e. active menstrual cycle) at the time of
 study entry:

 -  must not be pregnant

 -  and must be abstinent (and if so, this must be documented in the source documents at
 each vaccination visit)

 -  or must be using adequate contraceptive precautions (i.e. intrauterine contraceptive
 device, oral contraceptives, diaphragm or condom in combination with contraceptive
 jelly, cream or foam, progestogen-only implantable cutaneous hormonal patch or
 injectable contraceptives) for 30 days prior to vaccination and must agree to continue
 such precautions for one month after completion of the vaccination series.

 Exclusion Criteria:

 -  Use of any investigational or non-registered product (drug or vaccine) other than the
 study vaccine within 30 days preceding the first dose of study vaccine, or planned use
 during the study period and up to one month after the last vaccine dose.

 -  Subjects who have delivered recently or breastfeeding women must have completed a
 period of at least 3 months post-pregnancy and should not be breast-feeding in
 order to be enrolled in the study.

 Planning to become pregnant or likely to become pregnant (as determined by the
 investigator) or planning to discontinue contraceptive precautions during the study period.

 -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
 immune-modifying drugs on 14 consecutive days within six months prior to the first
 vaccine dose and up to one month after the last dose of the vaccine. (For
 corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled
 and topical steroids are allowed).

 -  Planned administration/administration of a vaccine not foreseen by the study protocol
 within 30 days before (Days - 1 to - 30) and 30 days (i.e. Days 0 - 29) after the
 first dose of vaccine. However, the administration of tetanus toxoid vaccine up to 8
 days before the first dose of study vaccine is allowed. Enrolment will be deferred
 until the subject is outside of specified window.

 -  Previous vaccination against HPV or planned administration of any HPV vaccine other
 than that foreseen by the study protocol during the study period.

 -  Any medically diagnosed or suspected immunodeficient condition such as human
 immunodeficiency virus (HIV) infection based on medical history and physical
 examination (no laboratory testing required).

 -  History of allergic disease, suspected allergy or reactions likely to be exacerbated
 by any component of the study vaccines, e.g. AS04, aluminium, MPL.

 -  Hypersensitivity to latex (found in syringe-tip cap and plunger).

 -  Known acute or chronic, clinically significant system conditions, e.g.
 neurologic,pulmonary, cardiovascular, hepatic, renal functional abnormality or
 psychiatric disorders, as determined by medical history, physical examination or
 previous laboratory tests.

 -  History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or
 kidney disease(s), diabetes, or autoimmune disease. This exclusion criterion should be
 understood as exclusion of subjects having significant medical conditions (such as
 cancer, autoimmune diseases) currently under treatment.

 -  Acute disease at the time of enrolment. Acute disease is defined as the presence of a
 moderate or severe illness with or without fever. Enrolment will be deferred until
 condition is resolved. All vaccines can be administered to persons with a minor
 illness such as diarrhoea, mild upper respiratory infection with or without low-grade
 febrile illness, i.e. oral/ axillary temperature < 37.5 °C (99.5 °F).

 -  A subject with body temperature (i.e. fever) > 37.5 °C (99.5 °F).

 -  Drug and/or alcohol abuse.