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Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00120848
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition or disease Intervention/treatment Phase
Infections, Papillomavirus Biological: HPV 16/18 VLP AS04 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of the Efficacy of Candidate HPV 16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Adolescent & Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299/001
Study Start Date : November 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007



Primary Outcome Measures :
  1. Incident cervical infection with HPV-16 and/or HPV-18

Secondary Outcome Measures :
  1. Persistent cervical infection (6-month definition) with HPV 16 and/or HPV 18.
  2. Persistent cervical infection (6-month definition) with oncogenic HPV types.
  3. Incident cervical infection with oncogenic HPV types.
  4. Histopathologically-confirmed CIN 1+ or CIN 2+ associated with HPV 16 and/or HPV 18 detected within the lesional component of the cervical tissue specimen.
  5. Histopathologically-confirmed CIN 1+ or CIN 2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen.
  6. Abnormal cytology associated with an HPV-16 and/or HPV-18 cervical infection.
  7. Abnormal cytology associated with oncogenic HPV type cervical infection.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participated in study 580299/001 and received all three doses of vaccine/placebo.
  • Written informed consent obtained from the subject prior to enrollment

Exclusion Criteria:

  • Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120848


Locations
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United States, California
GSK Investigational Site
San Francisco, California, United States, 94110
GSK Investigational Site
San Francisco, California, United States, 94143-0503
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912-3500
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
GSK Investigational Site
Morristown, New Jersey, United States, 07960
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77058
GSK Investigational Site
San Antonio, Texas, United States, 78205-2489
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
West Jordan, Utah, United States, 84084
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98105
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Brazil
GSK Investigational Site
Curitiba, Paraná, Brazil, 80060-900
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
GSK Investigational Site
Campinas, Brazil, 13083-970
GSK Investigational Site
Fortaleza, Brazil
GSK Investigational Site
São Paulo, Brazil, 01409 902
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 0W3
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1E 2C2
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 580299/007
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Katherine A et al. (2012) Adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use. Adis Drug Eval Drug Prof. 28(3):1-6.
Schwarz TF et al. (2011) Overview of clinical evidence: Cervarix. Future Medicine - Human Papillomavirus Vaccines. 38-50.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00120848    
Other Study ID Numbers: 580299/007
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
HPV vaccine efficacy
Prophylaxis HPV 16/18 infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases