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Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents

Phase 3
9 Years
15 Years
Not Enrolling
Human Papillomavirus (HPV) Infection, Papillomavirus Vaccines

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Trial Information

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents

Inclusion Criteria:

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

- A female between, and including, 9 and 15 years of age (has not attained her 16th
birthday) at the time of the first vaccination.

- 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 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 not be pregnant.

- Subjects must be of non-childbearing potential, or if the subject is of childbearing
potential, she must be abstinent or use adequate contraception for 30 days prior to
vaccination and must agree to continue such precautions 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 vaccines within 30 days preceding the first dose of study vaccine, or planned
use during the study period (up to Month 12).

- Concurrently participating in another clinical study, at any time during the study
period (up to the Month 12 telephone contact), in which the subject has been or will
be exposed to an investigational or a non-investigational product (pharmaceutical
product or device).

- 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 each dose of vaccine(s). Administration of
routine vaccines may be allowed up to 8 days before the first dose

- A subject planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the study period and up to two months
after the last vaccine dose.

- Pregnant or breastfeeding women.

- 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.

- Previous vaccination against hepatitis A or B planned administration of any hepatitis
A or B vaccine other than that foreseen by the study protocol during the study

- History of hepatitis A or B infection.

- Known exposure to hepatitis A or B within the previous 6 weeks.

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

- Cancer or autoimmune disease under treatment.

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

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

- Acute disease at the time of enrolment.

- 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

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-hepatitis A (Anti-HAV) Antibodies

Outcome Description:

Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.

Outcome Time Frame:

At Month 7

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Hungary: Országos Gyógyszerészeti Intézet

Study ID:




Start Date:

December 2007

Completion Date:

April 2009

Related Keywords:

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