Last updated: 11/07/2018 15:03:53

Human Papilloma virus vaccine safety and immunogenicity trial in young adolescent women with GSK Bio HPV-16/18.

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GSK study ID
580299/013
See study documents
Clinicaltrials.gov ID
NCT00196924
EudraCT ID
2004-000518-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluate the safety and immunogenicity of GSK Biologicals’ HPV-16/18 vaccine administered intramuscularly according to a 0,1,6 month schedule in healthy female subjects (10 – 14 years)
Trial description: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: HPV-16/18 L1/AS04
    • Enrollment:
    2067
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):332-340.
    Medina DM et al. (2010) Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomised, controlled trial in adolescent girls. J Adolesc Health. 46(5):414-421.
    Schwarz TF et al. (2012) Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 50(2):187-194.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    June 2004 to March 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    10 - 14 years
    Accepts healthy volunteers
    Yes
    • A woman between, and including, 10 and 14 years of age at the time of the first vaccination.
    • Written informed consent from the subject prior to enrolment.
    • Pregnant or breastfeeding.
    • Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A woman between, and including, 10 and 14 years of age at the time of the first vaccination. Written informed consent from the subject prior to enrolment. Subject must be free of obvious health problems. Subject must have negative urine pregnancy test.
    Exclusion criteria:
    • Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality. History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease. Previous vaccination against human papillomavirus (HPV).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wolfenbuettel, Niedersachsen, Germany, 38302
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Deggingen, Baden-Wuerttemberg, Germany, 73326
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint Sebastien de Morsent, France, 27180
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Verneuil sur Avre, France, 27130
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24944
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    North Adelaide, South Australia, Australia, 5006
    Status
    Study Complete
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    Showing 1 - 6 of 61 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-01-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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