Back to resultsV501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
Primary Purpose
HPV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
Comparator: Placebo (unspecified)
Sponsored by
About this trial
This is an interventional prevention trial for HPV Infections
Eligibility Criteria
Inclusion Criteria:
- Virginal Female Subject Aged 9 To 17 Years
Exclusion Criteria:
- Male Subject
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
V501
Placebo
Arm Description
V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.
Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen
Outcomes
Primary Outcome Measures
Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) 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".
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (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".
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (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".
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (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".
Secondary Outcome Measures
HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series
Month 30 HPV cLIA Geometric Mean Titers by vaccine group.
Full Information
NCT ID
NCT00411749
First Posted
December 14, 2006
Last Updated
March 23, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00411749
Brief Title
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
Official Title
V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 11, 2006 (Actual)
Primary Completion Date
September 18, 2009 (Actual)
Study Completion Date
September 18, 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
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
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
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V501
Arm Type
Experimental
Arm Description
V501 vaccination Quadrivalent HPV (Types 6, 11, 16,
18) L1 VLP Vaccine Injection
cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6,
Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
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 (unspecified)
Intervention Description
Placebo 0.5 ml injection in 3 dosing regimen
Primary Outcome Measure Information:
Title
Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
Description
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) 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
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
Description
Month 7 HPV Competitive Luminex immunoassay (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
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
Description
Month 7 HPV Competitive Luminex immunoassay (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
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
Description
Month 7 HPV Competitive Luminex immunoassay (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)
Secondary Outcome Measure Information:
Title
HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series
Description
Month 30 HPV cLIA Geometric Mean Titers by vaccine group.
Time Frame
24 month after completed vaccination series (Month 30)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Virginal Female Subject Aged 9 To 17 Years
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
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
Learn more about this trial
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
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