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Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

Phase 3
18 Years
Not Enrolling
Human Papillomavirus (HPV) Type 16/18 Infections and Cervical Neoplasia.

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Trial Information

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study

- A subject previously enrolled in the primary study (NCT00122681), who received the
active control hepatitis A vaccine, and who cannot receive commercially available
HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure
in the subject's country or because the subject is above the age for which the
vaccine is licensed.

- Written informed consent must be obtained from the subject prior to enrolment.

- A woman aged 18 years or older, at the time of the first vaccination in this study.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Subjects must not be pregnant. Absence of pregnancy should be verified with a urine
pregnancy test.

- Subject must be of non-childbearing potential, or if she is of childbearing
potential, she must practice adequate contraception for 30 days prior to vaccination,
have a negative pregnancy test and continue such precautions for 2 months after
completion of the vaccination series.

Exclusion Criteria:

- Pregnant or lactating female. Enrolment should be deferred until three months after
pregnancy has been completed or after lactating has ceased.

- A woman planning to become pregnant or likely to become pregnant (as determined by
the investigator) or planning to discontinue contraceptive prevention during the
study period and up to two months after the last vaccine dose.

- 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 and the extended safety follow-up period.

- 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
non-investigational product (pharmaceutical product or device).

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

- Planned administration/ administration of a vaccine not foreseen by the study
protocol within 30 days (i.e. Day 0-29) of each dose of vaccine. 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 is allowed. Enrolment will be deferred until the subject
is outside of specified window.

- Previous administration of components of the investigational vaccine.

- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study vaccine.

- Hypersensitivity to latex.

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

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

- Cancer or autoimmune disease under treatment.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

- Acute disease at the time of enrolment.

Type of Study:


Study Design:

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

Outcome Measure:

Occurrence, intensity and causal relationship to vaccination of serious adverse events

Outcome Time Frame:

Throughout the study.

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

August 2012

Related Keywords:

  • Human Papillomavirus (HPV) Type 16/18 Infections and Cervical Neoplasia.
  • papillomavirus
  • HPV vaccine
  • cervical cancer
  • HPV
  • human papillomavirus
  • Neoplasms



GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Bettendorf, Iowa  52722
GSK Investigational Site Oklahoma City, Oklahoma  73112
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Kansas City, Kansas  66160
GSK Investigational Site Omaha, Nebraska  68131
GSK Investigational Site Oregon City, Oregon  97045
GSK Investigational Site Seattle, Washington  98133
GSK Investigational Site Honolulu, Hawaii  96826