Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US
NCT ID: NCT00799825
Last Updated: 2018-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
346 participants
INTERVENTIONAL
2009-01-01
2012-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Cervarix group
Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
GSK Biological's HPV vaccine GSK580299 (Cervarix™)
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
Interventions
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GSK Biological's HPV vaccine GSK580299 (Cervarix™)
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Louisville, Colorado, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Iowa City, Iowa, United States
GSK Investigational Site
Arkansas City, Kansas, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Lebanon, New Hampshire, United States
GSK Investigational Site
Morristown, New Jersey, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Poughkeepsie, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
New Bern, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Carnegie, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Webster, Texas, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Spokane, Washington, United States
GSK Investigational Site
Wenatchee, Washington, United States
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Langley, British Columbia, Canada
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
Waterloo, Ontario, Canada
GSK Investigational Site
Beauport, Quebec, Canada
GSK Investigational Site
Gatineau, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
Countries
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Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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111955
Identifier Type: -
Identifier Source: org_study_id
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