A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.
Condition: Human Papillomavirus Infection Leading to Cervical Cancer
MeSH terms: Papillomavirus Infections
Intervention: Cervarix
Intervention description: Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 743.0
Sex: Female
Minimum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervarix; Filipinos; Safety and reactogenicity; Human papillomavirus

Summary:

      The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals'
      Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per
      the Bureau of Food and Drugs Directive of Philippines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             vaccination series.

        Exclusion Criteria:

          -  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
             laboratory tests.

          -  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.