Post-marketing Surveillance Study to Monitor Safety of Vaccination (Accor to Prescribing Information) With GlaxoSmithKline Biologicals' Human Papillomavirus Vaccine (HPV-16/18 L1/AS04) in Healthy Filipino Females (3,000; Aged >/= 10 Yrs)
- Subjects who the investigator believes that they and/or their LAR's can and will
comply with the requirements of the protocol should be enrolled in the study.
- A female 10 years of age and above at the time of the first vaccination.
- Written informed consent obtained from the subject. For subjects below the legal age
of consent, written informed consent must be obtained from the parent or legal
guardian (legally acceptable representative -LAR) of the subject and informed assent
must be obtained from the subject.
- Free of obvious health problems as established by medical history and
history-directed physical examination before entering into the study.
- Subjects of childbearing potential must not be pregnant.
- Subjects must be of non-childbearing potential, or if the subject is of childbearing
potential, she must be abstinent (and if so, this must be documented in the source
documents at each vaccination visit) or must be using adequate contraception for 30
days prior to vaccination and continue for 2 months after completion of the
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.
- 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
non-investigational product (pharmaceutical product or device).
- Pregnant or breastfeeding.
- Planning to become pregnant or likely to become pregnant (as determined by the
investigator) or planning to discontinue contraceptive prevention during the study
period and up to two months after the last vaccine dose.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study vaccine.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- Known acute or chronic, clinically significant neurologic, haematological, hepatic or
renal functional abnormality, as determined by previous physical examination or
- Cancer or autoimmune disease under treatment
- Previous vaccination against HPV or planned administration of another HPV vaccine
during the study.
- Acute disease at the time of enrolment.