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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
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Secondary ID [1]
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IISP50939
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Universal Trial Number (UTN)
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Trial acronym
Impress
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of Penile HPV Genotypes
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Assessment method [1]
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Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array.
Participants provided a single penile sample.
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Timepoint [1]
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Single study visit (one time point per participant)
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Eligibility
Key inclusion criteria
- Male
- Aged 17 to 19
- Able to complete study requirements
- Residing in Australia from 12 years of age
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Minimum age
17
Years
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Maximum age
19
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
-Males reporting sex with males in the past 12 months
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/12/2017
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Sample size
Target
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Accrual to date
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Final
345
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Sexual Health Centre - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02003508
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marcus Y Chen, PhD
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Address
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Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02003508
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