Back to resultsBroad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
Primary Purpose
HPV, Cervical Cancer, Premalignancy Anogenital Warts
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: Gardasil
Comparator: octavalent HPV Vaccine - dose formulation 1
Comparator: octavalent HPV Vaccine - dose formulation 2
Comparator: octavalent HPV Vaccine - dose formulation 3
Sponsored by
About this trial
This is an interventional prevention trial for HPV
Eligibility Criteria
Inclusion Criteria: Lifetime history of 0-4 sexual partners Exclusion Criteria: History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Gardasil
HPV VLP vaccine -Dose regimen 1
HPV VLP vaccine -Dose regimen 2
HPV VLP vaccine -Dose regimen 3
Outcomes
Primary Outcome Measures
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
Secondary Outcome Measures
Full Information
NCT ID
NCT00260039
First Posted
November 28, 2005
Last Updated
June 5, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00260039
Brief Title
Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
Official Title
A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (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
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV, Cervical Cancer, Premalignancy Anogenital Warts
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
680 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Gardasil
Arm Title
2
Arm Type
Experimental
Arm Description
HPV VLP vaccine -Dose regimen 1
Arm Title
3
Arm Type
Experimental
Arm Description
HPV VLP vaccine -Dose regimen 2
Arm Title
4
Arm Type
Experimental
Arm Description
HPV VLP vaccine -Dose regimen 3
Intervention Type
Biological
Intervention Name(s)
Comparator: Gardasil
Intervention Description
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
Intervention Type
Biological
Intervention Name(s)
Comparator: octavalent HPV Vaccine - dose formulation 1
Intervention Description
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Intervention Type
Biological
Intervention Name(s)
Comparator: octavalent HPV Vaccine - dose formulation 2
Intervention Description
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Intervention Type
Biological
Intervention Name(s)
Comparator: octavalent HPV Vaccine - dose formulation 3
Intervention Description
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Primary Outcome Measure Information:
Title
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
Time Frame
4 weeks post dose 3 injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Lifetime history of 0-4 sexual partners
Exclusion Criteria:
History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
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
Citations:
PubMed Identifier
25912208
Citation
Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010.
Results Reference
background
Learn more about this trial
Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
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