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Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01190189
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : December 17, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Condition or disease Intervention/treatment Phase
Infections, Papillomavirus Biological: GSK580299 (Cervarix) Phase 3

Detailed Description:
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study
Actual Study Start Date : April 1, 2011
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : November 23, 2017

Arm Intervention/treatment
Experimental: Cervarix Group
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Biological: GSK580299 (Cervarix)
3-dose schedule intramuscularly vaccination




Primary Outcome Measures :
  1. Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Month 12) ]
    Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.

  2. Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) [ Time Frame: During the entire study period (from Day 0 up to Month 12) ]
    Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.

  3. Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs) [ Time Frame: During the entire study period (from Day 0 up to Month 12) ]
    pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.

  4. Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies [ Time Frame: During the entire study period (from Day 0 up to Month 12) ]
    Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
  • Written informed consent obtained from the subject
  • 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.
  • A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. 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. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
  • 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, 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.

NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:

  • if they test positive for oncogenic HPV infection, but display normal cervical cytology at their concluding HPV-015 study end visit;
  • if they are pregnant so that no cervical sample can be taken at their concluding HPV-015 study end visit;

    • Previous administration of any components of the vaccine.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • Cancer or autoimmune disease under treatment.
    • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    • 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.
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190189


Locations
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United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Miami, Florida, United States, 33136
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
GSK Investigational Site
New Bern, North Carolina, United States, 28562
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Erie, Pennsylvania, United States, 16507
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5A 4L8
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Waterloo, Ontario, Canada, N2L 6H6
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
GSK Investigational Site
Quebec, Canada, G1S 2L6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] January 13, 2011
Statistical Analysis Plan  [PDF] September 25, 2015


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01190189    
Other Study ID Numbers: 113621
First Posted: August 27, 2010    Key Record Dates
Results First Posted: December 17, 2018
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Serious adverse events (SAEs)
HPV vaccine
Medically significant conditions
Cervical neoplasia
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs