Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
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
2 other identifiers
interventional
680
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2005
CompletedFirst Posted
Study publicly available on registry
December 1, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJune 8, 2015
June 1, 2015
1.7 years
November 28, 2005
June 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4 weeks post dose 3 injection
Study Arms (4)
1
ACTIVE COMPARATORGardasil
2
EXPERIMENTALHPV VLP vaccine -Dose regimen 1
3
EXPERIMENTALHPV VLP vaccine -Dose regimen 2
4
EXPERIMENTALHPV VLP vaccine -Dose regimen 3
Interventions
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Eligibility Criteria
You may qualify if:
- Lifetime history of 0-4 sexual partners
You may not qualify if:
- History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25912208BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2005
First Posted
December 1, 2005
Study Start
December 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
June 8, 2015
Record last verified: 2015-06