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A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.

Phase 2
20 Years
25 Years
Not Enrolling
Human Papillomavirus (HPV) Infection, Papillomavirus Vaccines, Cervical Neoplasia

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Trial Information

A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.

The Protocol Posting has been updated to reflect changes as a consequence of an amendment to
the protocol. Sections impacted are Official Title of the study and Intervention name.

Inclusion Criteria

Inclusion criteria :

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

- A Japanese female subject between, and including, 20 and 25 years of age at the time
of the first vaccination.

- Written informed consent obtained from the subject prior to enrolment.

- Healthy subjects as established by medical history and history-oriented clinical
examination before entering into the study.

- Subjects must have a negative urine pregnancy test.

- Subjects must be of non-childbearing potential, she must be abstinent or have used
adequate contraceptive precautions for 30 days prior to vaccination, have a negative
pregnancy test and must agree to continue such precautions for two months after
completion of the vaccination series.

- Subject must have an intact cervix

Exclusion criteria:

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

- Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and
not breastfeeding to enter the study.

- A women planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the study period, up to 2 months after
the last vaccine dose

- previous administration of components of the investigational vaccine

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study
protocol within 30 days before and 30 days after the first dose of vaccine. Routine
vaccines may be allowed up to 8 days before the first dose of study vaccine.

- Previous vaccination against HPV.

- History of vaccination against hepatitis A or a known clinical history of hepatitis A

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

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

- History of allergic disease or reactions likely to be exacerbated by any component of
the study vaccines

- Hypersensitivity to latex

- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
hepatic or renal functional abnormality, as determined by previous physical
examination or laboratory tests.

- Cancer or autoimmune disease under treatment.

- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
cervical cytology (Pap smear) test.

- Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be

- Acute disease at the time of enrolment.

- Oral temperature >= 37.5°C / axillary temperature > 37.5°C.

- 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 a
non-investigational product (pharmaceutical product or device).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)

Outcome Description:

Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6].

Outcome Time Frame:

Throughout the study period (up to Month 24)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Pharmaceutical and Medical Device Agency

Study ID:




Start Date:

April 2006

Completion Date:

February 2009

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • Papillomavirus Vaccines
  • Cervical Neoplasia
  • HPV Vaccine Efficacy
  • Neoplasms