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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01249365
First received: November 24, 2010
Last updated: January 16, 2017
Last verified: January 2017
  Purpose
This extension study is designed to assess the safety of GSK Biological's 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 Intervention Phase
Infections, Papillomavirus
Biological: GSK580299 (CervarixTM)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and causal relationship to vaccination of serious adverse events [ Time Frame: Throughout the study (from Month 0 to 12) ]
  • Occurrence, intensity and causal relationship to vaccination of medically significant conditions (including potential immune-mediated diseases) [ Time Frame: Throughout the study (from Month 0 to 12) ]
  • Occurrence of pregnancies and pregnancy outcomes [ Time Frame: Throughout the study (from Month 0 to 12) ]

Estimated Enrollment: 465
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects received control vaccine in the primary study NCT00294047
Biological: GSK580299 (CervarixTM)
3-dose schedule intramuscularly vaccination

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.
  Eligibility

Ages Eligible for Study:   26 Years and older   (Adult, Senior)
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 the 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.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249365

Locations
Australia, Victoria
GSK Investigational Site
Parkville, Victoria, Australia, 3052
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia
Portugal
GSK Investigational Site
Almada, Portugal, 2805-267 Almada
GSK Investigational Site
Coimbra, Portugal, 3000-075 Coimbra
GSK Investigational Site
Lisboa, Portugal, 1200-831 Lisboa
GSK Investigational Site
Porto, Portugal, 4200-023 Porto
GSK Investigational Site
Setúbal, Portugal, 2910-446 Setúbal
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620073
GSK Investigational Site
Moscow, Russian Federation, 109263
GSK Investigational Site
Moscow, Russian Federation, 115478
GSK Investigational Site
Moscow, Russian Federation, 117997
GSK Investigational Site
Sankt-Petersburg, Russian Federation, 190020
GSK Investigational Site
Sankt-Petersburg, Russian Federation, 199034
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 229899
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01249365     History of Changes
Other Study ID Numbers: 113618 
Study First Received: November 24, 2010
Last Updated: January 16, 2017

Keywords provided by GlaxoSmithKline:
medically significant conditions
cervical neoplasia
serious adverse events (SAEs)
HPV vaccine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 24, 2017