Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
Primary Purpose
Cervical Cancer, Vulvar Cancer, Vaginal Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: V505 formulation 1
Comparator: V505 formulation 2
Comparator: V505 formulation 2
Comparator: V505 formulation 3
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
Comparator: Placebo (unspecified)
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Female between 16 to 26 years old
- Has never had Pap testing or have only had normal Pap test results
- Lifetime history of 0 to 4 sexual partners
Exclusion Criteria:
- History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
- History of severe allergic reaction that required medical attention
- Are pregnant
- Received a marketed HPV vaccine
- Currently enrolled in a clinical trial
- Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
Outcomes
Primary Outcome Measures
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
Secondary Outcome Measures
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
Full Information
NCT ID
NCT00520598
First Posted
August 22, 2007
Last Updated
November 25, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00520598
Brief Title
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
Official Title
A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
511 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
Arm Title
2
Arm Type
Experimental
Arm Description
Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
Arm Title
3
Arm Type
Experimental
Arm Description
Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
Arm Title
4
Arm Type
Experimental
Arm Description
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
Arm Title
5
Arm Type
Experimental
Arm Description
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
Intervention Type
Biological
Intervention Name(s)
Comparator: V505 formulation 1
Intervention Description
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Intervention Type
Drug
Intervention Name(s)
Comparator: V505 formulation 2
Intervention Description
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Intervention Type
Drug
Intervention Name(s)
Comparator: V505 formulation 2
Intervention Description
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
Intervention Type
Biological
Intervention Name(s)
Comparator: V505 formulation 3
Intervention Description
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
Intervention Type
Biological
Intervention Name(s)
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
Intervention Description
0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Primary Outcome Measure Information:
Title
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
Time Frame
4 weeks post dose 3
Secondary Outcome Measure Information:
Title
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
Time Frame
4 weeks post dose 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female between 16 to 26 years old
Has never had Pap testing or have only had normal Pap test results
Lifetime history of 0 to 4 sexual partners
Exclusion Criteria:
History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
History of severe allergic reaction that required medical attention
Are pregnant
Received a marketed HPV vaccine
Currently enrolled in a clinical trial
Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
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
Learn more about this trial
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
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