Clinical trial NCT00799825: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US
Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: papillomavirus
HPV vaccine
cervical cancer
HPV
human papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 346
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
timeFrame: Throughout the study (up to Month 12)
measure: Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
timeFrame: Throughout the study (up to Month 12)
measure: Number of Subjects With Pregnancies and Pregnancy Outcomes.
timeFrame: Throughout the study (up to Month 12)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Louisville
country: United States
facility: GSK Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Arkansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Newton
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Morristown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Carnegie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pleasant Hills
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Webster
country: United States
facility: GSK Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Langley
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: St. John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Waterloo
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Beauport
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: