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Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00811798
First received: December 18, 2008
Last updated: September 8, 2011
Last verified: September 2011
History of Changes

December 18, 2008
September 8, 2011
May 2009
September 2010   (final data collection date for primary outcome measure)
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. [ Time Frame: During the entire study period (Day 0 up to the telephone contact at Month 12). ] [ Designated as safety issue: No ]
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Occurrence of any serious adverse event (SAE) and SAE(s) causally related to vaccination. [ Time Frame: During the entire study period (Day 0 up to the telephone contact at Month 12). ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00811798 on ClinicalTrials.gov Archive Site
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Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Subjects.

This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HPV-16/18 Infections and Associated Cervical Neoplasia.
  • Papillomavirus Vaccines
Biological: Cervarix
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Experimental: Cervarix Group
Intervention: Biological: Cervarix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide [Al(OH)3]).
  • A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday.
  • Written informed consent obtained from the subject (prior to enrolment).
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects must have a negative urine pregnancy test.
  • Subjects must be of non-childbearing potential or, if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for two months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study 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 non-investigational product (pharmaceutical product or device).
  • Pregnant or breastfeeding.
  • Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
  • Hypersensitivity to latex (found in syringe-tip cap and plunger).
  • Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
  • Cancer or autoimmune disease under treatment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Previous administration of an adjuvant that used in the HPV-16/18 vaccine.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
  • Acute disease at the time of enrolment.
Female
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00811798
111712
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

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