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Gynaecological Follow-up of a Subset of HPV-015 Study Subjects


Phase 3
28 Years
N/A
Open (Enrolling)
Female
Human Papillomavirus Infection, Cervical Neoplasia

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Trial Information

Gynaecological Follow-up of a Subset of HPV-015 Study Subjects


Cervarix™ or control [Al(OH)3] has been administered in the primary study NCT00294047.


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.

- A subject previously enrolled in the study NCT00294047 and who fulfils either of the
following criteria:

- displayed normal cervical cytology but tested positive for oncogenic HPV
infection at her concluding NCT00294047 study visit

- was pregnant so that no cervical sample could be collected at her concluding
NCT00294047 study visit

Exclusion Criteria:

- A subject who at the NCT00294047 concluding study visit displayed normal cervical
cytology and who was negative for oncogenic HPV infection at that visit.

- A subject who at the NCT00294047 concluding study visit had a cervical lesion at that
visit or who had a cervical lesion that required treatment at her NCT00294047 exit
colposcopy.

- A subject for whom the cervical cytology results from the concluding NCT00294047
study visit were unavailable for reasons other than pregnancy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing

Outcome Time Frame:

Throughout the study (month 12 to month 48 post last study visit study NCT00294047)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Peru: Instituto Nacional de Salud

Study ID:

113617

NCT ID:

NCT01190176

Start Date:

September 2011

Completion Date:

April 2018

Related Keywords:

  • Human Papillomavirus Infection
  • Cervical Neoplasia
  • HPV
  • HPV vaccine
  • Cervical neoplasia
  • Human papillomavirus
  • Papillomavirus
  • Cervical cancer
  • Human papillomavirus (HPV) type 16/18 infections
  • Neoplasms
  • Warts
  • Papillomavirus Infections

Name

Location
GSK Investigational Site Bettendorf, Iowa  52722
GSK Investigational Site Kansas City, Kansas  66160
GSK Investigational Site Seattle, Washington  98133