Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

Human Papillomavirus Clinical Trial

— Impress  

Official title:

Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003508
• Other study ID #: IISP50939
• Status: Completed
• Start date: January 2014
• Est. completion date: December 29, 2017

Study information

• Verified date: March 2020
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 17 Years to 19 Years

Eligibility

Inclusion Criteria:

• Male

• Aged 17 to 19

• Able to complete study requirements

• Residing in Australia from 12 years of age

Exclusion Criteria:

-Males reporting sex with males in the past 12 months

Related Conditions & MeSH terms

• Human Papillomavirus
• Papillomavirus Infections

Locations

Country	Name	City	State
Australia	Melbourne Sexual Health Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
The Alfred	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Penile HPV Genotypes	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.	Single study visit (one time point per participant)