Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090220
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2004-08-25
Brief Title:
A Study to Evaluate the Safety Immune Response and Efficacy of Gardasil V501 qHPV in Mid-Adult Women V501-019
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Safety Immunogenicity and Efficacy of Gardasil V501 Human Papilloma Virus Types 6 11 16 18 Recombinant Vaccine in Mid-Adult Women - The FUTURE III Females United to Unilaterally Reduce EndoEctocervical Cancer Study
Status:
COMPLETED
Status Verified Date:
2017-03
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 assess the safety immunogenicity efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus HPV infection and disease in mid-adult women
Detailed Description:
The Base study vaccination period V501-019 encompassed Day 1 through Month 7 during which time participants received randomly assigned blinded Gardasil V501 qHPV vaccine or placebo at Day 1 Month 2 and Month 6 The Base study follow-up period continued through approximately Month 48
The base study was extended in protocol V501-019-10 EXT1 Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete open-label 3-dose qHPV vaccine regimen administered at EXT1 Day 1 Month 2 and Month 6 Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine administered at EXT1 Day 1 Participants were followed to EXT1 Month 7
A Long Term Follow-Up LTFU extension study V501-019-21 EXT2 was added to observe the long term safety effectiveness and immunogenicity of qHPV vaccine in approximately 1600 women who participated in the Base Study at sites in Colombia Data were collected over a period of 6-10 years following participants enrollment in the original Base Study
The base study was extended in protocol V501-019-10 EXT1 Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete open-label 3-dose qHPV vaccine regimen administered at EXT1 Day 1 Month 2 and Month 6 Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine administered at EXT1 Day 1 Participants were followed to EXT1 Month 7
A Long Term Follow-Up LTFU extension study V501-019-21 EXT2 was added to observe the long term safety effectiveness and immunogenicity of qHPV vaccine in approximately 1600 women who participated in the Base Study at sites in Colombia Data were collected over a period of 6-10 years following participants enrollment in the original Base Study
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 |
|---|---|---|---|
| 2004_013 | None | None | None |