GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: Female
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervical cancer; vulvar cancer; vaginal cancer; genital warts; human papillomavirus

Summary:

      The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose
      regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in
      Sub-Saharan Africa. Data from the current study are needed in order to complement existing
      extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™
      may be administered safely and will induce immune responses in populations from and living in
      Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Healthy subjects who are native to and living in a participating Sub-Saharan African
             country.

          -  Subject agrees to provide study personnel with a primary telephone number as well as
             an alternate telephone number for follow-up purposes. If potential subject does not
             have a telephone number, the subject must provide an address at which he or she may be
             contacted.

          -  Post-pubertal female subjects must not be pregnant

          -  Subjects who are sexually active must agree to use effective contraception or remain
             abstinent through Month 7 of the study.

          -  Subjects who have not yet had sexual intercourse must either agree to remain abstinent
             through Month 7 of the study, or if they become sexually active during the vaccination
             phase of the study, to use effective contraception through Month 7.

          -  Subjects who have had sexual intercourse in the two weeks prior to enrollment must
             have been using effective contraception as defined above. (Emergency contraception is
             not considered effective contraception for enrollment in the study.)

        Exclusion Criteria :

          -  Subject is pregnant as determined by a positive pregnancy test

          -  Subject has had a temperature ≥ 37.8 °C or ≥ 100 °F within 24 hours prior to the first
             injection.

          -  Subject is currently enrolled in another clinical study of an investigational agent or
             agents.

          -  Subject has a history of known prior vaccination with a HPV vaccine, or was previously
             enrolled in an HPV vaccine study and received either active agent or placebo.

          -  Subject has received any inactivated vaccine within 14 days prior to enrollment or any
             live vaccine within 21 days prior to enrollment.

          -  Subject has a history of severe allergic reaction to any agent (e.g., swelling of the
             mouth and throat, difficulty breathing, hypotension, or shock) that required medical
             intervention.

          -  Subject has known allergy to any vaccine component, including aluminum, yeast or
             BENZONASE™ (nuclease, Nycomed™ [used to remove residual nucleic acids from this and
             other vaccines]).

          -  Subject has received any immune globulin preparation or blood-derived products within
             the 6 months prior to the first injection, or plans to receive any such products
             during the course of the study.

          -  Subject has a history of splenectomy, known autoimmune disorder (e.g., systemic lupus
             erythematosus, rheumatoid arthritis), or is receiving immunosuppressives (e.g.,
             substances or treatments known to diminish immune response such as radiation therapy,
             administration of antimetabolites, antilymphocytic sera, systemic corticosteroids).
             Individuals who have received periodic treatments with immunosuppressives, defined as
             at least 3 courses of systemic corticosteroids each lasting at least 1 week in
             duration for the year prior to enrollment, will be excluded. Subjects using topical
             steroids (i.e., inhaled or nasal) will be eligible for vaccination.

          -  Subject is immunocompromised or has been diagnosed as having Human Immunodeficiency
             Virus (HIV) infection

          -  Subject has known thrombocytopenia or any coagulation disorder that would
             contraindicate intramuscular injections.

          -  Subject has known sickle cell anemia disease, active malaria or active tuberculosis.

          -  Subject has any condition which in the opinion of the investigator might interfere
             with the evaluation of the study objectives.

          -  Subject has a history of recent or ongoing alcohol or other drug abuse.

          -  Female subject has a prior history of abnormal Pap test showing squamous
             intraepithelial lesion (SIL), atypical squamous cells of undetermined significance
             (ASC-US), atypical squamous cells, cannot rule out a high grade lesion (ASC-H), or
             biopsy showing cervical intraepithelial neoplasia (CIN) or worse.

          -  Subject has any prior history (or at Day 1) of genital warts or treatment for genital
             warts.

          -  Subject with >4 lifetime sexual partners.

          -  Subject has undergone hysterectomy with removal of the cervix.

          -  Subject plans to permanently relocate from the area prior to the completion of the
             study or to leave for an extended period of time when study visits would need to be
             scheduled.