Back to resultsA Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
Primary Purpose
Cervical Cancer, Vulvar Cancer, Vaginal Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
V504
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Comparator: Placebo (unspecified)
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Females between 16- to 26-years-old
- Has never had Pap testing or has 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 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 the time of consent)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Outcomes
Primary Outcome Measures
Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
Secondary Outcome Measures
Seroconversion percentages to HPV types contained in the administered vaccines
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551187
Brief Title
A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
Official Title
A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 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 purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.
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
620 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Intervention Type
Biological
Intervention Name(s)
V504
Intervention Description
V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Intervention Type
Biological
Intervention Name(s)
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Intervention Description
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
V504 Placebo in 3 dose regimen for 6 month treatment period.
Primary Outcome Measure Information:
Title
Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
Time Frame
4 weeks post dose 3
Secondary Outcome Measure Information:
Title
Seroconversion percentages to HPV types contained in the administered vaccines
Time Frame
4 weeks post dose 3
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:
Females between 16- to 26-years-old
Has never had Pap testing or has 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 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 the 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
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
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A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
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