NCT02296255

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
832

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

November 11, 2014

Last Update Submit

November 19, 2014

Conditions

Cervical Cancer

Keywords

cervical cancer screeningyoung women vaccinationimpact of HPV vaccination on screening

Outcome Measures

Primary Outcomes (2)

  • number of HR-HPV infections and number of infections due to HPV vaccine types in cervical sample in the Experimental arm and in No intervention arm

    30 months

  • number of cytological abnormalities in the Experimental arm and in No intervention arm

    30 months

Secondary Outcomes (6)

  • Number of subjects seropositive for HPV 16, 18, 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 at enrollment

    enrollment

  • Number of subjects seropositive for HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 after vaccination

    30 months

  • Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers before vaccination

    at enrollment

  • Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers after vaccination

    30 months

  • Number of participants reporting Adverse Events

    within 14 days following any injection

  • +1 more secondary outcomes

Study Arms (2)

no HPV vaccine

NO INTERVENTION

No delivery of HPV vaccine

HPV vaccine (Cervarix®, GlaxoSmithKline)

EXPERIMENTAL

Delivery of HPV vaccine (Cervarix®, GlaxoSmithKline) at 0, 1, 6 months

Biological: Cervarix®, GlaxoSmithKline

Interventions

Cervarix®, GlaxoSmithKlineBIOLOGICAL

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

HPV vaccine (Cervarix®, GlaxoSmithKline)

Eligibility Criteria

Age25 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • resident in Florence
  • invited for the first time to the cervical cancer screening in Florence
  • aged 25 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Prevention and Research Institute, ISPO

Florence, FI, 50139, Italy

Location

Related Publications (3)

  • Levi M, Bonanni P, Burroni E, Bechini A, Boccalini S, Sani C, Bonaiuti R, Indiani L, Azzari C, Lippi F, Carozzi F; HPV Screevacc Working Group. Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women. Hum Vaccin Immunother. 2013 Jul;9(7):1407-12. doi: 10.4161/hv.24337. Epub 2013 Apr 9.

    PMID: 23571176RESULT

  • Burroni E, Bonanni P, Sani C, Lastrucci V, Carozzi F; Hpv ScreeVacc Working Group; Iossa A, Andersson KL, Brandigi L, Di Pierro C, Confortini M, Levi M, Boccalini S, Indiani L, Sala A, Tanini T, Bechini A, Azzari C. Human papillomavirus prevalence in paired urine and cervical samples in women invited for cervical cancer screening. J Med Virol. 2015 Mar;87(3):508-15. doi: 10.1002/jmv.24085. Epub 2014 Nov 21.

    PMID: 25418873RESULT

  • Carozzi FM, Ocello C, Burroni E, Faust H, Zappa M, Paci E, Iossa A, Bonanni P, Confortini M, Sani C. Effectiveness of HPV vaccination in women reaching screening age in Italy. J Clin Virol. 2016 Nov;84:74-81. doi: 10.1016/j.jcv.2016.09.011. Epub 2016 Oct 3.

    PMID: 27728850DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

human papillomavirus vaccine, L1 type 16, 18halofantrine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Francesca M Carozzi, PhD

    Cancer Prevention and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biologist Director

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 20, 2014

Study Start

April 1, 2010

Primary Completion

May 1, 2011

Study Completion

July 1, 2013

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

IT(1)