Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix; Procedure: Gynaecological follow-up; Biological: Placebo control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190176

113617

2009-017282-35 (EudraCT Number)

Details and patient eligibility

About

This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit.

Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit.

The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

Full description

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

Enrollment: 34 patients

Sex: Female

Ages: 28+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

HPV-062 study subjects Group

Experimental group

Description:

HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.

Treatment:

Biological: Cervarix

Biological: Placebo control

Procedure: Gynaecological follow-up