Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-08-23
First Post:
2004-09-23
Brief Title:
Cervical Intraepithelial Neoplasm CIN in Women Gardasil V501-015
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Worldwide Placebo-Controlled Double-Blind Study to Investigate the Safety Immunogenicity and Efficacy on the Incidence of HPV 1618-Related CIN 23 or Worse of the Quadrivalent HPV Types 6 11 16 18 L1 Virus-Like Particle VLP Vaccine in 16- to 23-Year Old Women - The FUTURE II Study Females United to Unilaterally Reduce EndoEctocervical Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-08
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:
FUTURE II
Brief Summary:
The primary purpose of the study is to determine if GARDASIL V501 is able to prevent cervical cancer
Detailed Description:
In the 4-year Base Study V501-015 NCT00092534 participants were randomized in a 11 order to receive 3 doses of GARDASIL or matching placebo at Day 1 Month 2 and Month 6 and were assessed for efficacy immunogenicity and safety
In the Base Study Extension EXT V501-015-10 participants who received placebo or only 1 dose of GARDASIL in the Base Study were given 3 doses of open-label GARDASIL at EXT Day 1 EXT Month 2 and EXT Month 6 and were followed to EXT Month 7 Participants who who received 2 doses of GARDASIL in the Base Study were given 1 dose of GARDASIL at EXT Day 1 and were followed for 15 days day of vaccination plus 14 days
In the 10-year Base Study Long-Term Follow-Up LTFU V501-015-21 the effectiveness immunogenicity and safety of GARDASIL was assessed during a period of 10 years following completion of the Base Study V501-015 14 years after the first dose of GARDASIL and for some measures the Base Study EXT V501-015-10 10 years after the first dose of GARDASIL Participants from Denmark Iceland Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU Effectiveness and safety was assessed by registry-based follow-up and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU
An 8-year extension was added to the LTFU V501-015-22 to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASIL Effectiveness and safety will be assessed by registry-based follow-up and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU
In the Base Study Extension EXT V501-015-10 participants who received placebo or only 1 dose of GARDASIL in the Base Study were given 3 doses of open-label GARDASIL at EXT Day 1 EXT Month 2 and EXT Month 6 and were followed to EXT Month 7 Participants who who received 2 doses of GARDASIL in the Base Study were given 1 dose of GARDASIL at EXT Day 1 and were followed for 15 days day of vaccination plus 14 days
In the 10-year Base Study Long-Term Follow-Up LTFU V501-015-21 the effectiveness immunogenicity and safety of GARDASIL was assessed during a period of 10 years following completion of the Base Study V501-015 14 years after the first dose of GARDASIL and for some measures the Base Study EXT V501-015-10 10 years after the first dose of GARDASIL Participants from Denmark Iceland Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU Effectiveness and safety was assessed by registry-based follow-up and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU
An 8-year extension was added to the LTFU V501-015-22 to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASIL Effectiveness and safety will be assessed by registry-based follow-up and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU
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_082 | None | None | None |
| V501-015 | OTHER | Merck | None |