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

Phase 3
25 Years
Not Enrolling
HPV-16/18 Infections and Associated Cervical Neoplasia., Papillomavirus Vaccines

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Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

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.

Outcome Description:

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.

Outcome Time Frame:

During the entire study period (Day 0 up to the telephone contact at Month 12).

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Hong Kong: Department of Health

Study ID:




Start Date:

May 2009

Completion Date:

September 2010

Related Keywords:

  • HPV-16/18 Infections and Associated Cervical Neoplasia.
  • Papillomavirus Vaccines
  • Hong Kong
  • Human papillomavirus
  • Safety
  • Neoplasms