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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00120848
First received: July 12, 2005
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Papillomavirus Infection
Biological: HPV 16/18 VLP AS04
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: 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

Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 776
Study Start Date: November 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: HPV 16/18 VLP AS04
    Other Name: HPV 16/18 VLP AS04
  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders 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.
  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: NCT00120848

  Show 25 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00120848     History of Changes
Other Study ID Numbers: 580299/007
Study First Received: July 12, 2005
Last Updated: October 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HPV vaccine efficacy
Prophylaxis HPV 16/18 infections

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

ClinicalTrials.gov processed this record on September 18, 2014