Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
MeSH terms: Infections
Intervention: Cervarix; Placebo control
Intervention description: Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.; Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5752.0
Sex: Female
Minimum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Human papillomavirus; Cervical Cancer; Cervical Infection

Summary:

      This is a multicentre study in which women were planned to receive either the Human
      Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study
      participation will last approximately 48 months and involves a total of eleven scheduled
      visits. Under Protocol Amendment 4, study participation will last up to 84 months and
      involves a maximum of seventeen scheduled visits.
    

Eligibility criteria:

        Inclusion criteria:

          -  A woman who the investigator believes that she can and will comply with the
             requirements of the protocol.

          -  A women of at least 26 years of age at the time of the first vaccination.

          -  Written informed consent obtained from the subject prior to enrolment.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Subject must have intact cervix.

          -  Subject must have a negative urine pregnancy test. This test is not applicable to
             women of non-childbearing potential.

          -  Subject must be of non-childbearing potential or, if of childbearing potential, she
             must be abstinent or must be using an effective method of birth control for 30 days
             prior to the first vaccination and must agree to continue such precautions for two
             months after completion of the vaccination series.

        Exclusion criteria:

          -  Pregnant or breastfeeding (women must be at least three months post-pregnancy and not
             breastfeeding to enter the study).

          -  A women planning to become pregnant, likely to become pregnant (as determined by the
             investigator) or planning to discontinue contraceptive precautions during the
             vaccination phase of the study, i.e. up to two months after the last vaccine dose
             (Month 0 - 8).

          -  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 (up to Month 84).

          -  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 study
             vaccine. Planned administration/administration of routine vaccines 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 administration of components of the investigational vaccine

          -  Previous vaccination against HPV or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period.

          -  History of HPV infection/treatment or planned treatment to evaluate an abnormal
             cervical cytology (Pap smear) test, e.g. colposcopy.

          -  Any medically diagnosed or suspected immunodeficient condition based on medical
             history and physical examination.

          -  History of allergic disease, suspected allergy or reactions likely to be exacerbated
             by any component of the study vaccine.

          -  Hypersensitivity to latex.

          -  Known acute or chronic, clinically significant neurologic, hepatic or renal functional
             abnormality, as determined by previous physical examination or laboratory tests.

          -  History of chronic condition(s) requiring treatment.

          -  Administration of immunoglobulins and/or any blood product within three months
             preceding the first dose of study vaccine, or planned administration during the study
             period. Enrolment will be deferred until the subject is outside of specified window.

          -  Acute disease at the time of enrolment.

          -  Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic
             exam cannot be performed (and no cervical sample can be taken). Enrolment will be
             deferred until condition is resolved according to investigators medical judgement.