Gynaecological follow-up of a subset of 580299/008 study subjects

• Conditions: GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.; MedDRA version: 15.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-008124-33-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-08
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 2000

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 HPV-008 and who fulfils either of the following criteria:
displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48).
or was pregnant at her last visit of the HPV-008 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48).
A subject who had a cervical lesion at her last HPV-008 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the HPV-008 exit colposcopy.
A subject for whom the cervical cytology results from the last HPV-008 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified