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

Phase 3
9 Years
15 Years
Not Enrolling
Human Papillomavirus Infection

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Trial Information

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

Inclusion Criteria:

- Subjects who the investigator believes that they and/or their parents/legally
acceptable representatives (LARs) can and will comply with the requirements of the
protocol (e.g. completion of the diary cards, return for follow-up visits) 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's parent/LAR prior to the
enrolment. In addition, 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. Absence of pregnancy should be verified with a urine
pregnancy test.

- If the subject is female, she must be of non-childbearing potential, or if she is of
childbearing potential, she must practice adequate contraception for at least 30 days
prior to vaccination, have a negative pregnancy test and continue such precautions
for two months after completion of the vaccination series. Subjects who reach
menarche (begin menstruating) during the study, and therefore become of childbearing
potential, must agree to 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 (up to Month 12).

- 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. Administration of
routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus
and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of
study vaccine is allowed.

- 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).

- A subject planning to become pregnant, likely to become pregnant (as determined by
the investigator) 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 B or planned administration of any hepatitis B
vaccine other than that foreseen by the study protocol during the study period.

- History of hepatitis B infection.

- Known exposure to hepatitis 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 With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection

Outcome Description:

Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.

Outcome Time Frame:

Month 7

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Sweden: Medical Products Agency

Study ID:




Start Date:

April 2008

Completion Date:

August 2009

Related Keywords:

  • Human Papillomavirus Infection
  • Co-administration
  • HPV vaccine
  • Cervical cancer
  • Warts
  • Papillomavirus Infections