Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090285
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2004-08-25
Brief Title:
An Investigational Study of Gardasil qHPV Vaccine in Reducing the Incidence of Anogenital Warts in Young Men V501-020
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted to demonstrate that Gardasil quadrivalent human papillomavirus qHPV vaccine 1 is well tolerated in young men 2 reduces incidence of external genital lesions in young men 3 reduces the incidence of anal intraepithelial neoplasia AIN or anal cancer in men having sex with men MSM and 4 reduces incidence of Human Papillomavirus HPV infection in young men In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1 Month 2 and Month 6 Base Study follow-up continued through Month 36 In Extension 1 EXT1 participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine Participants were followed in EXT1 for 7 months In Extension 2 LTFU EXT2 long-term effectiveness immunogenicity and safety of qHPV vaccine were followed up to 10 years following study enrollment Participants who received 1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU EXT2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Formerly-0904HPVHMES | None | None | None |
| 2004_103 | None | None | None |
| 2004-002945-10 | EUDRACT_NUMBER | None | None |
| V501-020 | OTHER | Merck Protocol Number | None |