Clinical trial · Interventional
Effect of HPV Vaccination on Women Aged 25 Years
Effective Surveillance and Impact of HPV Vaccination on Screening for Cervical Cancer in Tuscany
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix®, GlaxoSmithKline | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- no HPV vaccine
- description
- No delivery of HPV vaccine
- type
- EXPERIMENTAL
- label
- HPV vaccine (Cervarix®, GlaxoSmithKline)
- description
- Delivery of HPV vaccine (Cervarix®, GlaxoSmithKline) at 0, 1, 6 months
- interventionNames
- Biological: Cervarix®, GlaxoSmithKline
Primary outcomes (2)
- measure
- 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
- timeFrame
- 30 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * resident in Florence * invited for the first time to the cervical cancer screening in Florence * aged 25 years Exclusion Criteria: \-
References
Publications (3)
- RESULTLevi 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 23571176
- RESULTBurroni 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 25418873
- DERIVEDCarozzi 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 27728850