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Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa

Phase 3
9 Years
26 Years
Not Enrolling
Papillomavirus Infections

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Trial Information

Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa

Inclusion Criteria

Inclusion Criteria :

- Healthy subjects who are native to and living in a participating Sub-Saharan African

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of Participants who Seroconvert to Human Papillomavirus (HPV) Type 6

Outcome Time Frame:

Month 7 (1 month postdose 3)

Safety Issue:



Kenya: Pharmacy and Poisons Board

Study ID:




Start Date:

March 2011

Completion Date:

April 2013

Related Keywords:

  • Papillomavirus Infections
  • Cervical cancer
  • vulvar cancer
  • vaginal cancer
  • genital warts
  • human papillomavirus
  • Papillomavirus Infections