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
  Purpose

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).


Condition Intervention Phase
HPV-16/18 Infections and Associated Cervical Neoplasia.
Papillomavirus Vaccines
Biological: Cervarix
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Subjects.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Enrollment: 92
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group Biological: Cervarix
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811798

Locations
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00811798     History of Changes
Other Study ID Numbers: 111712
Study First Received: December 18, 2008
Results First Received: September 8, 2011
Last Updated: September 8, 2011
Health Authority: Hong Kong: Department of Health

Keywords provided by GlaxoSmithKline:
Hong Kong
Human papillomavirus
Safety

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 10, 2014