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Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study

Phase 3
26 Years
Open (Enrolling)
Human Papillomavirus Infection

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Trial Information

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study

Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of
the protocol.

- A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in
Study HPV-001 (NCT00689741), and who is 26 years of age or older.

- Written informed consent must be 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.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and has agreed to continue
adequate contraception during the entire treatment period and for 2 months after
completion of the vaccination series.

Exclusion Criteria:

- Pregnant or breastfeeding: enrolment should be deferred to at least three months
after delivery and after breastfeeding is ceased.

- A woman planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the vaccination phase of the study, and
up to two months after the last vaccine dose.

- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of study vaccine, or planned use during the
study period.

- Previous vaccination against HPV or planned administration of another HPV vaccine
during the study other than that foreseen in the protocol.

- 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 of each dose of the vaccine, with the exception of administration of
routine meningococcal, hepatitis B, hepatitis A, inactivated influenza,
diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before
each dose of study vaccine. Enrolment will be deferred until the subject is outside
of specified window.

- 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 a
non-investigational product.

- Previous administration of vaccine components.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- Cancer or autoimmune disease under treatment.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.

- History of any neurological disorders or seizures.

- Acute disease and/or fever at the time of enrolment. Enrolment will be deferred until
condition is resolved.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests, which in the opinion of the investigator precludes administration of the study

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Occurrence of medically significant conditions and potential immune-mediated diseases (pIMDs).

Outcome Time Frame:

Throughout the study period (from Month 0 up to Month 12)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

April 2014

Related Keywords:

  • Human Papillomavirus Infection
  • HPV vaccine
  • serious adverse events (SAEs)
  • medically significant conditions
  • cervical neoplasia
  • Warts
  • Papillomavirus Infections