Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
June 5, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
680
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Gardasil
|
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
|
|
Experimental: 2
HPV VLP vaccine -Dose regimen 1
|
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
|
|
Experimental: 3
HPV VLP vaccine -Dose regimen 2
|
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
|
|
Experimental: 4
HPV VLP vaccine -Dose regimen 3
|
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
4 weeks post dose 3 injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
November 28, 2005
First Submitted That Met QC Criteria
November 28, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 5, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V502-001
- 2005_086
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.