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Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine co-Administered With Another Vaccine in Healthy Female Subjects
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00652938
  Purpose

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine as compared to the administration of either vaccine alone.


Condition Intervention Phase
Human Papillomavirus Infection
Biological: Engerix B
Biological: HPV Vaccine (GSK580299)
Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) co-Administrated With a Commercially Available Vaccine in Healthy Female Adolescents

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs seroprotection status in subjects receiving the HepB vaccine [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 seroconversion status in subjects receiving the HPV-16/18 vaccine [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 antibody titres in subjects receiving the HPV-16/18 vaccine. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-HPV-16/18 seroconversion status and antibody titres in subjects receiving the HPV vaccine. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Anti-HBs seroconversion and seroprotection status and antibody titres in subjects receiving the HepB vaccine. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Occurrence of any and Grade 3 solicited local symptoms (injection site pain, redness and swelling) in all study groups. [ Time Frame: During the 7-day period (Days 0 - 6) following each and any vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups. [ Time Frame: During the 7-day period (Days 0 - 6) following each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs in all study groups. [ Time Frame: During the 30-day period (Days 0 - 29) following any vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of any, Grade 3 and causally related to vaccination SAEs in all study groups. [ Time Frame: Throughout the active phase of the study (up to Month 7). ] [ Designated as safety issue: Yes ]
  • Occurrence of any, Grade 3 and causally related to vaccination SAEs in all study groups [ Time Frame: Throughout the safety follow-up (up to Month 12). ] [ Designated as safety issue: Yes ]
  • Occurrence of medically significant conditions in all study groups regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the active phase of the study (up to Month 7) ] [ Designated as safety issue: Yes ]
  • Occurrence of medically significant conditions in all study groups regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the safety follow-up (up to Month 12) ] [ Designated as safety issue: Yes ]
  • Anti-HBs seroconversion status and antibody titres in subjects receiving the HepB vaccine. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 756
Study Start Date: April 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Biological: HPV Vaccine (GSK580299)
IM administration
B: Experimental Biological: Engerix B
IM administration
Biological: HPV Vaccine (GSK580299)
IM administration
C: Active Comparator Biological: Engerix B
IM administration

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 tests.
  • 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 period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652938

Locations
Netherlands
GSK Investigational Site
ROTTERDAM, Netherlands, 3011 EN
GSK Investigational Site
NIJMEGEN, Netherlands, 6525 GA
Sweden
GSK Investigational Site
SKENE, Sweden, SE-511 62
GSK Investigational Site
MALMÖ, Sweden, SE-211 52
GSK Investigational Site
NORRKÖPING, Sweden, SE-601 82
GSK Investigational Site
LULEÅ, Sweden, SE-972 31
GSK Investigational Site
LINKÖPING, Sweden, SE-581 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111507
Study First Received: March 27, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00652938  
Health Authority: Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
HPV vaccine
Co-administration
Cervical cancer

Study placed in the following topic categories:
Virus Diseases
Skin Diseases, Infectious
Warts
Skin Diseases
DNA Virus Infections
Papillomavirus Infections
Healthy

Additional relevant MeSH terms:
Skin Diseases, Viral
Neoplasms
Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009