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Human Papillomavirus (HPV) Vaccine Consistency and Non-Inferiority Trial in Young Adult Women.
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00337818
  Purpose

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 GSK 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.

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.


Condition Intervention Phase
HPV-16/18 Infections and Cervical Neoplasia
Biological: HPV-16/18 L1/AS04
Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Month 18, 24, 36 & 48 FU. 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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HPV-16 and anti-HPV-18 antibody titers assessed by ELISA in all subjects [ Time Frame: At each time point (Months 18, 24, 36 and 48) ]

Secondary Outcome Measures:
  • Occurrence of pregnancies, SAEs, new onset chronic diseases and other medically significant conditions [ Time Frame: Throughout the study period ]
  • Anti-HPV-16 and anti-HPV-18 antibody titers assessed by ELISA [ Time Frame: At each time point (Months 0, 7, 18, 24, 36 and 48) ]
  • Anti-HPV-16 and anti-HPV-18 antibody titers from subjects enrolled in studies HPV-001/HPV-007 subjects assessed by ELISA [ Time Frame: At each time point ]
  • Anti-HPV-16 and anti-HPV-18 antibody titers in cervical samples in post-menarcheal subjects who volunteered for the procedure. [ Time Frame: At Months 24, 36 and 48 ]
  • Total IgG evaluation in blood samples [ Time Frame: At Months 24, 36 and 48 ]

Estimated Enrollment: 400
Study Start Date: June 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

In the extension phases at Month 18, 24, 36 & 48, no new subjects will be recruited. No vaccination will be administered during this extension phase.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A female who enrolled in the HPV-012 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337818

Locations
Denmark
GSK Clinical Trials Call Center
Copenhagen, Denmark
Estonia
GSK Clinical Trials Call Center
Tallinn, Estonia
Finland
GSK Clinical Trials Call Center
Seinajoki, Finland
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

Primary Study  This link exits the ClinicalTrials.gov site

Responsible Party: GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers: 107476 (M18), 107477 (M24), 107479 (M36), 107481 (M48)
Study First Received: June 15, 2006
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00337818  
Health Authority: Estonia: The State Agency of Medicine

Keywords provided by GlaxoSmithKline:
HPV Vaccine Consistency
Immunogenicity
Non-inferiority

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009