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Effect of HPV Vaccination on Women Aged 25 Years

NCT02296255 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 832

Last updated 2014-11-20

No results posted yet for this study

Summary

The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old women at the time of their first access to cervical cancer screening, to understand the impact of vaccination on screening activity; to evaluate the immune response following vaccination; to study the dynamics of the infection after vaccination, including the possible change in the frequency of non-vaccine HPV types, to evaluate cytological abnormalities reductions in vaccinated women and to assess if HPV test in urine sample could be a useful non-invasive method to monitor HPV status in younger women.

Conditions

Interventions

BIOLOGICAL

Cervarix®, GlaxoSmithKline

3 doses (0,1,6 months) of Cervarix®, GlaxoSmithKline

Sponsors & Collaborators

  • Istituto Toscano Tumori

    collaborator OTHER

  • University of Florence

    collaborator OTHER

  • Cancer Prevention and Research Institute, Italy

    lead OTHER

Principal Investigators

  • Francesca M Carozzi, PhD · Cancer Prevention and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-05-31
Completion
2013-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT02296255 on ClinicalTrials.gov