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. Identifier: NCT01190189
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : June 1, 2018
Information provided by (Responsible Party):

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.

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
Study Start Date : April 1, 2011
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : November 23, 2017

Arm Intervention/treatment
Experimental: Group A
Subjects received control vaccine in the primary study NCT00294047
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 Month 0 to Month 12) ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.

  2. Number of subjects reporting any, Grade 3 and related medically significant conditions (MAEs) [ Time Frame: During the entire study period (From Month 0 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) routine visits for physical examination or vaccination, or 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.

  3. Number of subjects with potentially Immune-Mediated Diseases (pIMDs) [ Time Frame: During the entire study period (From Month 0 to Month 12) ]
    pIMD(s) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

  4. Number of subjects with pregnancies and their outcomes [ Time Frame: During the entire study period (From Month 0 to Month 12) ]
    Pregnancy outcomes are live infant, premature live infant, elec-tive termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).

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

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 identifier (NCT number): NCT01190189

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01190189     History of Changes
Other Study ID Numbers: 113621
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Keywords provided by GlaxoSmithKline:
Serious adverse events (SAEs)
HPV vaccine
Medically significant conditions
Cervical neoplasia

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs