Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Condition: Infections, Papillomavirus
Intervention: Cervarix; Engerix-B
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34412.0
Sex: All
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine; Healthy adolescents; Cervical cancer; Safety; Immunogenicity; Cervarix

Summary:

      Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and
      women. The most important disease associated with oncogenic HPV infection is cervical cancer,
      currently the second leading cause of cancer-related death among women globally. The current
      study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15
      years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study participants who the investigator or delegate believes that they and/or their
             parents/legally acceptable representative can and will comply with the requirements of
             the protocol (e.g. completion of the diary cards, return for follow-up visits) should
             be enrolled in the study.

          -  A male or female between, and including, 12 and 15 years of age at the time of the
             first vaccination.

        A written informed assent must be obtained from all study participants prior to enrolment.
        In addition, a written informed consent must be obtained from the study participants'
        parent or legally acceptable representative.

        Note: As according to the Finnish law legal age of consent is 15 years, a written informed
        consent form can be obtained from study participants aged 15 years old and their
        parent(s)/legally acceptable representative(s) will receive a letter informing them of
        their child participation to the study.

          -  Healthy male and female study participants as established by medical history before
             entering into the study. If needed, a history-directed clinical examination will be
             performed by the investigator or delegate (e.g. study nurse).

          -  Study participants must not be pregnant. Absence of pregnancy should be verified (e.g.
             urine pregnancy test) as per investigator's or delegate's clinical judgement.

          -  If the study participant is female, she must be of non-childbearing potential, i.e. be
             abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be
             post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must
             use adequate contraception for 30 days prior to vaccination and continue for 2 months
             after completion of the vaccination series.

        Exclusion Criteria:

          -  Previous vaccination against HPV or Hepatitis B virus.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  Acute disease at the time of enrolment. (Acute disease is defined as the presence of a
             moderate or severe illness with or without fever. 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 temperature <37.5°C (99.5°F) /
             Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).)

          -  Pregnant or lactating female.