Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

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: NCT00231413
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):

October 3, 2005
October 4, 2005
September 23, 2016
March 2005
March 2006   (Final data collection date for primary outcome measure)
Evaluation of immune response of the novel HPV vaccine at different dosages at month 7.
Same as current
Complete list of historical versions of study NCT00231413 on Archive Site
Vaccine immunogenicity. Safety of the novel HPV vaccine in entire study period.
Same as current
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Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)
Human Papilloma viruses (HPV) are viruses that cause infections 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, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Infections, Papillomavirus
Biological: Novel HPV vaccine
Not Provided
Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2006
March 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A woman between, and including, 18 and 25 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 be of non-childbearing potential and have had no more than 6 lifetime sexual partners.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8).
  • 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)
Sexes Eligible for Study: Female
18 Years to 25 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
September 2016

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