Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy Study of HPV-16/18 Vaccine (GSK 580299) to Prevent HPV-16 and/or -18 Cervical Infection in Young Healthy Women

This study has been completed.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00689741
First received: May 30, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women. A vaccine that prevents, or even reduces, the incidence of the common types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant reduction in the incidence of cervical cancer and cancer-related mortality, as well as a reduction in the incidence of surgical procedures following abnormal Pap smears.


Condition Intervention Phase
Papillomavirus Infections
Biological: Cervarix
Biological: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Placebo-Controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cervical infection with HPV-16 and/or HPV-18 [ Time Frame: Throughout the study ]

Secondary Outcome Measures:
  • Persistent cervical infection with HPV-16 and/or HPV-18 [ Time Frame: Throughout the study ]
  • Cytologically confirmed or histopathologically confirmed LSIL, HSIL, squamous cell cancer, or adenocarcinoma concurrently associated with HPV-16 and/or HPV-18 cervical infection [ Time Frame: Throughout the study ]
  • Determination of viral load for HPV-16 and HPV-18 (by PCR) for both self-obtained and Pap smear cervical samples [ Time Frame: Throughout the study ]
  • Cervical infection with HPV-16, HPV-18 and/or HPV-16/18-related phylogenetic types [ Time Frame: Throughout the study ]
  • Persistent cervical infection with HPV-16, HPV-18 and/or HPV-16/18-related phylogenetic types [ Time Frame: Throughout the study ]
  • Cytologically confirmed or histopathologically confirmed LSIL, HSIL, squamous cell cancer, adenocarcinoma concurrently associated with cervical infection with HPV-16; HPV-18 and/or HPV-16/18-related phylogenetic types. [ Time Frame: Throughout the study ]

Enrollment: 1113
Study Start Date: January 2001
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: Cervarix
3 doses of IM injection
Other Name: GSK HPV-16/18 VLP vaccine (GSK580299)
Placebo Comparator: B Biological: placebo
3 doses of IM injection of Al(OH)3 placebo

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female between and including 15 and 25 years of age at the time of screening (must not have reached 26th birthday)
  • Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must also be obtained from a parent or legal guardian of the subject)
  • Free of obvious health problems, as established by medical history and a directed physical examination
  • No more than 6 lifetime sexual partners prior to enrolment
  • Intact uterus
  • Subject must be of non-childbearing potential, i.e., either surgically sterilised or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
  • For subjects not enrolled in the HPV epidemiology study (999910/106) and for subjects completing the study (999910/106) >90 days prior to enrolment in the present study: agreement to complete both entrance and exit study questionnaires concerning general personal information, and sexual, contraceptive, reproductive and other gynaecological medical history
  • For subjects previously enrolled in the HPV epidemiology study (and who completed the study and an entrance questionnaire) ≤ 90 days prior to enrolment in the present study: agreement to complete the exit questionnaire only.
  • Normal cervical cytology (Pap smear) at screening, using the Cytyc ThinPrep® Pap Test. A normal Pap smear must also be adequate for interpretation, including the presence of endocervical cells; a Pap smear that is normal but inadequate for interpretation must be repeated as part of the protocol
  • Seronegative for HPV-16 and HPV-18 antibody by ELISA at screening
  • HPV DNA PCR negative for high-risk HPV types by PCR at screening. Genotyping will be specified using a reverse line probe assay specific for the detection of high-risk HPV types such as HPV-16, HPV-18 and HPV-16/18-related phylogenetic types

Exclusion Criteria:

  • Pregnant or lactating female
  • Female planning to become pregnant during the first eight months of the study (months 0-8)
  • Abnormal vaginal discharge at the time of entry (once these subjects have received therapy to eradicate any discharge they will be eligible to participate in study)
  • Previous administration of any components of the investigational vaccine
  • Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period
  • Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine. Administration of routine Meningococcal, Hepatitis A, Hepatitis B, Influenza, and Diphtheria/Tetanus vaccine up to 8 days before the first dose of study vaccine is allowed
  • Use of any investigational or non-registered 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
  • Receiving or expecting therapy for external or internal condylomata. Subjects with external condylomata not requiring therapy are eligible to participate in the study
  • Genital herpes disease involving the cervix or characterized (on examination or by history) by extensive external lesions. Subjects with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study
  • History of an abnormal cervical cytology (Pap smear) test (other than a single prior report of ASCUS with a subsequent normal report)
  • Treatment for cervical disease by ablative therapy (cryotherapy or laser ablation) or excisional therapy (laser cone biopsy, loop excision, cold-knife conization)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • A family history of congenital or hereditary immunodeficiency
  • Major congenital defects or serious chronic illness
  • History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
  • Acute disease at the time of enrolment.
  • Oral temperature ≥99.5°F (≥37.5°C) / axillary temperature ≥99.5°F (37.5°C) / rectal temperature ≥100.4°F (≥38.0°C) / tympanic temperature on oral setting ≥99.5°F (37.5°C) / tympanic temperature on rectal setting ≥100.4°F (≥38.0°C)
  • History of chronic alcohol consumption and/or intravenous drug abuse within the past 2 years
  • Known or suspected allergy to any vaccine component
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689741

  Hide Study Locations
Locations
United States, California
GSK Clinical Trials Call Center
San Francisco, California, United States, 94110
GSK Clinical Trials Call Center
San Francisco, California, United States, 94118
United States, Florida
GSK Clinical Trials Call Center
Miami, Florida, United States, 33136
United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30328
GSK Clinical Trials Call Center
Augusta, Georgia, United States, 30912
United States, Kentucky
GSK Clinical Trials Call Center
Bardstown, Kentucky, United States, 40004
GSK Clinical Trials Call Center
Louisville, Kentucky, United States, 40202
United States, New Hampshire
GSK Clinical Trials Call Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
GSK Clinical Trials Call Center
Morristown, New Jersey, United States, 07960
United States, New Mexico
GSK Clinical Trials Call Center
Albuquerque, New Mexico, United States, 87131
United States, Oregon
GSK Clinical Trials Call Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, United States, 19107
GSK Clinical Trials Call Center
Pittsburgh, Pennsylvania, United States, 15421
United States, Texas
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75234
GSK Clinical Trials Call Center
Houston, Texas, United States, 77058
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78207
United States, Utah
GSK Clinical Trials Call Center
Salt Lake City, Utah, United States, 84109
GSK Clinical Trials Call Center
West Jordan, Utah, United States, 84084
United States, Washington
GSK Clinical Trials Call Center
Seattle, Washington, United States, 98105
United States, Wisconsin
GSK Clinical Trials Call Center
Marshfield, Wisconsin, United States, 54449
Brazil
GSK Clinical Trials Call Center
Aldeota Fortaleza, Ceára, Brazil, 60135-200
GSK Clinical Trials Call Center
Porto Alegre, Rio Grande do Sul, Brazil
GSK Clinical Trials Call Center
Campinas, Brazil, 13083-970
GSK Clinical Trials Call Center
Curitiba, Brazil, 13083-970
GSK Clinical Trials Call Center
São Paulo, Brazil, 03015-000
Canada, British Columbia
GSK Clinical Trials Call Center
Langley, British Columbia, Canada, V3A 4H9
Canada, Manitoba
GSK Clinical Trials Call Center
Winnipeg, Manitoba, Canada, R3E OW3
Canada, Ontario
GSK Clinical Trials Call Center
Toronto, Ontario, Canada, M4N 3M5
Canada
GSK Clinical Trials Call Center
Edmonton, Canada, AB T6G 2C8
GSK Clinical Trials Call Center
St John's, Canada, NF A1E 2C2
Puerto Rico
GSK Clinical Trials Call Center
Carolina, Puerto Rico, 00983
Sponsors and Collaborators
GlaxoSmithKline
MedImmune LLC
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Isabelle Harpigny, GSK Biologicals
ClinicalTrials.gov Identifier: NCT00689741     History of Changes
Other Study ID Numbers: 580299/001
Study First Received: May 30, 2008
Last Updated: May 30, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HPV
vaccine

Additional relevant MeSH terms:
Communicable Diseases
Infection
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014