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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


Phase 2
20 Years
30 Years
Not Enrolling
Female
Papillomavirus Infection

Thank you

Trial Information

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


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.

Type of Study:

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

Outcome Measure:

Incident cervical infection with HPV-16 and/or HPV-18

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

580299/007

NCT ID:

NCT00120848

Start Date:

November 2003

Completion Date:

July 2007

Related Keywords:

  • Papillomavirus Infection
  • HPV vaccine efficacy
  • Prophylaxis HPV 16/18 infections
  • Papillomavirus Infections

Name

Location
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Green Bay, Wisconsin  54301
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Edison, New Jersey  08837
GSK Investigational Site Oregon City, Oregon  97045
GSK Investigational Site Salt Lake City, Utah  84107
GSK Investigational Site Seattle, Washington  98133