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Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects

Phase 1
15 Years
45 Years
Not Enrolling
Human Papillomavirus (HPV) Infection, Papillomavirus Vaccines

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Trial Information

Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects

The rationale for the protocol posting amendment was to change the study population from
18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g.
Hepatitis A&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis
etc. up to 8 days before each HPV dose.

Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.

- A female of Chinese origin, residing in China, aged between 15 - 45 years
(inclusive) at the time of the first vaccination.

- Written informed consent obtained from the subject. For subjects below the legal age
of consent, written informed consent must be obtained from the subject's parent or
Legally Acceptable Representative (LAR), and written informed assent must be obtained
from the subject.

- 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 or must be using adequate contraception for 30 days
prior to vaccination and continue for 2 months after completion of the vaccination

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- Pregnant or breastfeeding.

- Planning to become pregnant or likely to become pregnant

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study

- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days preceding and 30 days after the first dose of vaccine. Administration
of some routine vaccines up to 8 days before the first dose of study vaccine is

- Previous administration of components of the investigational vaccine.

- Previous vaccination against HPV or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination

- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study vaccine.

- Hypersensitivity to latex.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Known acute or chronic, clinically significant system conditions.

- Cancer or autoimmune disease under treatment.

- Acute disease at the time of enrolment.

- History of chronic alcohol consumption and/or drug abuse.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Subjects Reporting Serious Adverse Events

Outcome Description:

Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Outcome Time Frame:

Throughout the study period (up to Month 7)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

July 2008

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • Papillomavirus Vaccines
  • HPV vaccine,
  • Cervical cancer
  • Human papillomavirus infection,