Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
15 Years
25 Years
Female
HPV-16/18 Infections, Cervical Neoplasia
Trial Information
Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
In this extension study, women who were vaccinated in the primary study, and participated in
the follow-up study, will be followed for a further 3 years with visits every 6 months.
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.
- Subjects who participated in study 580299-007.
- Written informed consent obtained from the subject prior to enrollment.
Exclusion Criteria:
- Use or planned use of any investigational or non-registered product other than the
study vaccine.
- Decoding of the subject's 580299-001 treatment allocation to either the subject or
the investigator.
- Administration or planned administration of any other HPV vaccine, other than the
vaccine administered 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, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
Outcome Description:
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
Outcome Time Frame:
Up to year 8
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Brazil: ANVISA
Study ID:
109616 (Y7)
NCT ID:
NCT00518336
Start Date:
November 2007
Completion Date:
September 2010
Related Keywords:
- HPV-16/18 Infections
- Cervical Neoplasia
- Neoplasms
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