Know Cancer

forgot password

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years

Phase 3
15 Years
25 Years
Not Enrolling
HPV-16/18 Infections and Cervical Neoplasia

Thank you

Trial Information

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years

Inclusion Criteria:

- Subjects who the investigator believes that they and/or their parent(s)/Legally
acceptable representative(s) (LAR) can and will comply with the requirements of the

- A female between and including 15 and 25 years of age at the time of the first

- Written informed consent obtained from the subject prior to enrolment. For subjects
below the legal age of consent, written informed consent must be obtained from the
subject's parents/legally acceptable representative (LAR), and written informed
assent must be obtained from the subject.

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

- Subject must be of non-childbearing potential, or if she is of child bearing
potential, she must practice adequate contraception for 30 days prior to vaccination,
have a negative urine pregnancy test and continue such precautions for 2 months after
completion of the vaccination series.

- Subject who had no more than 6 lifetime sexual partners prior to enrolment.

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.

- 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. Planned
administration/administration of routine vaccines up to 8 days before the first dose
of study vaccine is allowed. Enrolment will be deferred until the patient is outside
of specified window.

- 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).

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

- 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.

- Administration of immunoglobulins and/or any blood products within the three months
preceding blood sampling.

- Pregnant or breastfeeding female.

- Female planning to become pregnant, likely to become pregnant (as determined by the
investigator) or planning to discontinue contraceptive precautions during the study
period starting at visit one and up to two months after the last vaccine dose.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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 after the third vaccine dose

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Slovakia: State Institute for Drug Control

Study ID:




Start Date:

November 2007

Completion Date:

July 2009

Related Keywords:

  • HPV-16/18 Infections and Cervical Neoplasia
  • HPV
  • cervical cancer
  • papillomavirus
  • Human papillomavirus (HPV) vaccine
  • Neoplasms