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Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

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ClinicalTrials.gov Identifier: NCT00337818
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : March 2, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 15, 2006
First Posted Date  ICMJE June 16, 2006
Results First Submitted Date  ICMJE November 12, 2009
Results First Posted Date  ICMJE March 2, 2010
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At months 18*, 24, 36 and 48 ]
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). *Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2006)
To evaluate the long-term immunogenicity of the HPV-16/18 L1/AS04 vaccine.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
  • Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples [ Time Frame: At months 24, 36, and 48 ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
  • Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples [ Time Frame: At Months 24, 36 and 48 ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
  • Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) [ Time Frame: Throughout the study period (up to Month 48) ]
    NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
  • Number of Subjects Reporting SAEs [ Time Frame: Throughout the study period (up to Month 48) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2006)
Safety of HPV vaccine during the entire study period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Official Title  ICMJE A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study
Brief Summary The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. 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 consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Detailed Description

Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Papillomavirus Type 16/18 Infection
  • Cervical Intraepithelial Neoplasia
Intervention  ICMJE Biological: Cervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Study Arms  ICMJE
  • Experimental: Cervarix New Process
    Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process.
    Intervention: Biological: Cervarix™
  • Experimental: Cervarix Old Process Group
    Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the old manufacturing process.
    Intervention: Biological: Cervarix™
  • Experimental: Cervarix Young/Lot 1 Group
    Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process (Lot 1).
    Intervention: Biological: Cervarix™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2010)
770
Original Enrollment  ICMJE
 (submitted: June 15, 2006)
400
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
  • Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study 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 a non-investigational product (pharmaceutical product or device).
  • Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
  • Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia
Removed Location Countries Denmark,   Finland
 
Administrative Information
NCT Number  ICMJE NCT00337818
Other Study ID Numbers  ICMJE 107476 (M18)
107477 ( Other Identifier: GSK )
107479 ( Other Identifier: GSK )
107481 ( Other Identifier: GSK )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP