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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02003508




Registration number
NCT02003508
Ethics application status
Date submitted
2/12/2013
Date registered
6/12/2013
Date last updated
6/03/2020

Titles & IDs
Public title
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
Scientific title
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
Secondary ID [1] 0 0
IISP50939
Universal Trial Number (UTN)
Trial acronym
Impress
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pre-school based vaccination program (not vaccine eligible) - Young (17-19 years) men who were not eligible for school based vaccination due to their age at the time of the programs roll out.

Post-school based vaccination program (vaccine eligible) - Young men (17-19 years) who were eligible for school based vaccination due to their age at the time of the programs roll out.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of Penile HPV Genotypes
Timepoint [1] 0 0
Single study visit (one time point per participant)

Eligibility
Key inclusion criteria
* Male
* Aged 17 to 19
* Able to complete study requirements
* Residing in Australia from 12 years of age
Minimum age
17 Years
Maximum age
19 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Males reporting sex with males in the past 12 months

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/12/2017
Sample size
Target
Accrual to date
Final
345
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.
Trial website
https://clinicaltrials.gov/study/NCT02003508
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcus Y Chen, PhD
Address 0 0
Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02003508