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Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.

Phase 3
10 Years
15 Years
Not Enrolling
Papillomavirus Vaccines

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Trial Information

Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.

Inclusion Criteria:

- Subjects who the investigator/co-investigator believes that they and/or their
parent(s)/legally acceptable representative(s) can and will comply with the
requirements of the protocol should be enrolled in the study.

- A Japanese female between, and including, 10 and 15 years of age at the time of the
first vaccination.

- Written informed consent obtained from the parent(s) or legally acceptable
representative(s) of the subject. In addition, a written informed assent must be
obtained from the subject prior to enrolment.

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

- All subjects must have a negative urine pregnancy test.

- Subjects must be of non-childbearing potential, or, if of childbearing potential,
they must be abstinent or have used adequate contraception 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. Non-abstinent
pre-menarche subjects, as well as subjects who reach menarche during study, must
follow the same precautions.

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.

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

- 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. Administration of
vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment
will be deferred until the subject is outside of specified window.

- Concurrently participating in another clinical study, at any time during the study
period (up to Month 7), in which the subject has been or will be exposed to an
investigational or a non-investigational product (pharmaceutical product or device).

- Previous vaccination against HPV, or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period (Day 0 to Month 7).

- Previous administration of components of the investigational vaccine .

- Cancer or autoimmune disease under treatment.

- 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 vaccine.

- Hypersensitivity to latex.

- Acute disease at the time of enrolment.

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

- 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

- Pregnant or breastfeeding subject.

- Subject planning to become pregnant or planning to discontinue contraceptive

- Oral temperature ≥ 37.5°C/Axillary temperature ≥ 37.5°C.

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 Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

Outcome Description:

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Outcome Time Frame:

One month post Dose 3 (Month 7)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

July 2007

Completion Date:

March 2008

Related Keywords:

  • Papillomavirus Vaccines
  • Human Papillomavirus (HPV) vaccine
  • safety
  • cervical cancer
  • immunogenicity
  • vaccine
  • viral infections
  • pre-adolescent and adolescent females