V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
Primary Purpose
HPV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Comparator: Placebo
Sponsored by
About this trial
This is an interventional prevention trial for HPV Infections
Eligibility Criteria
Inclusion Criteria:
- Female Subject Aged 18 To 26 Years
- With 1-4 Lifetime Sexual Partners
Exclusion Criteria:
- Male Subject
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
Vaccine
Outcomes
Primary Outcome Measures
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.
Secondary Outcome Measures
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.
The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
Full Information
NCT ID
NCT00378560
First Posted
September 18, 2006
Last Updated
March 20, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00378560
Brief Title
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
Official Title
V501 Phase II Efficacy Study in Women Aged 18 to 26
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 12, 2006 (Actual)
Primary Completion Date
September 16, 2009 (Actual)
Study Completion Date
September 16, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1021 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Vaccine
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Other Intervention Name(s)
V501, Gardasil
Intervention Description
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo 0.5 ml injection in 3 dosing regimen
Primary Outcome Measure Information:
Title
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
Description
Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.
Time Frame
Over 30 months
Secondary Outcome Measure Information:
Title
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
Description
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.
The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
Time Frame
At one month after completed vaccination series (Month 7)
Title
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
Description
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
Time Frame
At one month after completed vaccination series (Month 7)
Title
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
Description
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
Time Frame
At one month after completed vaccination series (Month 7)
Title
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
Description
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
Time Frame
At one month after completed vaccination series (Month 7)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female Subject Aged 18 To 26 Years
With 1-4 Lifetime Sexual Partners
Exclusion Criteria:
Male Subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
23331518
Citation
Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
Results Reference
result
PubMed Identifier
32827835
Citation
Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
Results Reference
derived
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V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
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