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Gynaecological Follow-up of a Subset of 580299/008 Study Subjects


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Human Papillomavirus (HPV) Type 16/18 Infections, Cervical Neoplasia

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Trial Information

Gynaecological Follow-up of a Subset of 580299/008 Study Subjects


Inclusion Criteria:



- Written informed consent obtained from the subject prior to enrolment.

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.

- A subject previously enrolled in the study NCT 00122681 and who fulfils either of the
following criteria:

- displayed normal cervical cytology but tested positive for oncogenic HPV infection at
her last NCT 00122681 study visit (Visit 10, Month 48).

or

• was pregnant at her last visit of the NCT 00122681 study (Visit 10, Month 48) so that no
cervical sample could be collected at that visit.

Exclusion Criteria:

- A subject who displayed normal cervical cytology and who was negative for oncogenic
HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).

- A subject who had a cervical lesion at her last NCT 00122681 study visit (Visit 10,
Month 48) or who had a cervical lesion that required treatment at the NCT 00122681
exit colposcopy.

- A subject for whom the cervical cytology results from the last NCT 00122681 study
visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.

If at the time of enrolment the subject experiences heavy bleeding (menstruation or other)
or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The
subject's first study visit will be deferred until condition is resolved according to
investigator's medical judgment.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Evaluation of the presence of oncogenic HPV DNA in cervical samples by HPV DNA testing

Outcome Time Frame:

Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Finland: Finnish Medicines Agency

Study ID:

112024

NCT ID:

NCT00937950

Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Human Papillomavirus (HPV) Type 16/18 Infections
  • Cervical Neoplasia
  • HPV
  • Papillomavirus
  • Human papillomavirus
  • Cervical cancer
  • HPV vaccine
  • Neoplasms

Name

Location

GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteAlbuquerque, New Mexico  87109
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHonolulu, Hawaii  96826