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

NCT01190176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-10-30

Study results available
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Summary

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.

Conditions

  • Infections, Papillomavirus

Interventions

PROCEDURE

Gynaecological follow-up

Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.

BIOLOGICAL

Cervarix

Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

BIOLOGICAL

Placebo control

Subjects received 3 doses of the control \[Al(OH)3\] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-12
Primary Completion
2017-09-20
Completion
2017-09-20

Countries

  • United States
  • Canada
  • Netherlands
  • Portugal
  • Russia
  • Singapore
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190176 on ClinicalTrials.gov