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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
-Males reporting sex with males in the past 12 months
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Males aged 17-19 recruited from sexual health clinics and community sources
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Y Chen, PhD | Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne Sexual Health Centre | Melbourne | Victoria | 3053 | Australia |
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Participants were recruited from clinical and community sources across Australia over a period of four years (February 2014- December 2017), which represented two phases. Participants recruited in phase 1 (2014-2015) were ineligible for school-based HPV vaccination. Participants in Phase 2(2016-2017) were eligible for school-based HPV vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 (2014-2015) | Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program. Accordingly, most of these men were unvaccinated against 4HPV. |
| FG001 | Phase 2 (2016-2017) | Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction. Accordingly, many participants in this group had received the HPV vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-vaccination Period | Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program. |
| BG001 | Post-vaccination Period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants in group one were ineligible for school-based vaccination. All participants in group two were eligible to receive 4vHPV vaccination. All participants had experienced sexual contact with a female (either oral or vaginal sex), no sexual contact (either oral or anal sex) with a male, and had assessable penile samples. | Posted | Number | 95% Confidence Interval | percentage of participants | Single study visit (one time point per participant) |
|
Single study visit per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 (2014-2015) | Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program. Nil adverse events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A/Prof Marcus Chen | Melbourne Sexual Health Centre | +613 93416260 | mchen@mshc.org.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2015 | Jul 24, 2019 | Prot_SAP_000.pdf |
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Penile sampling for HPV DNA
Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual contact in lifetime | Count of Participants | Participants |
|
| OG001 | Phase 2 (2016-2017) | Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction |
|
|
| 0 |
| 179 |
| 0 |
| 179 |
| 0 |
| 179 |
| EG001 | Phase 2 (2016-2017) | Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction. Nil adverse events. | 0 | 166 | 0 | 166 | 0 | 166 |
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