|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02296255 |
|
Date of registration:
|
11/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of HPV Vaccination on Women Aged 25 Years
|
|
Scientific title:
|
Effective Surveillance and Impact of HPV Vaccination on Screening for Cervical Cancer in Tuscany |
|
Date of first enrolment:
|
April 2010 |
|
Target sample size:
|
832 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02296255 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Francesca M Carozzi, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cancer Prevention and Research Institute |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- resident in Florence
- invited for the first time to the cervical cancer screening in Florence
- aged 25 years
Exclusion Criteria:
-
Age minimum:
25 Years
Age maximum:
25 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Cervical Cancer
|
|
Intervention(s)
|
|
Biological: Cervarix®, GlaxoSmithKline
|
|
Primary Outcome(s)
|
|
number of cytological abnormalities in the Experimental arm and in No intervention arm
[Time Frame: 30 months]
|
|
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
[Time Frame: 30 months]
|
|
Secondary Outcome(s)
|
|
Number of subjects seropositive for HPV 16, 18, 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 at enrollment
[Time Frame: enrollment]
|
|
Number of participants reporting Adverse Events
[Time Frame: within 14 days following any injection]
|
|
Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers before vaccination
[Time Frame: at enrollment]
|
|
HPV identification in urine samples
[Time Frame: at enrollment]
|
|
Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers after vaccination
[Time Frame: 30 months]
|
|
Number of subjects seropositive for HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 after vaccination
[Time Frame: 30 months]
|
|
Secondary ID(s)
|
|
342/2009
|
|
F11J09000350002
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|