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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00231413
First received: October 3, 2005
Last updated: September 22, 2016
Last verified: September 2016

October 3, 2005
September 22, 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. [ Designated as safety issue: No ]
Evaluation of immune response of the novel HPV vaccine at different dosages at month 7.
Complete list of historical versions of study NCT00231413 on ClinicalTrials.gov Archive Site
Vaccine immunogenicity. Safety of the novel HPV vaccine in entire study period. [ Designated as safety issue: No ]
Vaccine immunogenicity. Safety of the novel HPV vaccine in entire study period.
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
383
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)
Female
18 Years to 25 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium
 
NCT00231413
102115
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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