Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
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
2 other identifiers
interventional
511
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2007
CompletedFirst Posted
Study publicly available on registry
August 24, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 26, 2015
November 1, 2015
3.6 years
August 22, 2007
November 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
4 weeks post dose 3
Secondary Outcomes (1)
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
4 weeks post dose 2
Study Arms (5)
1
ACTIVE COMPARATORArm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
2
EXPERIMENTALArm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
3
EXPERIMENTALArm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
4
EXPERIMENTALArm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
5
EXPERIMENTALArm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
Interventions
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
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.
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVED
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
August 22, 2007
First Posted
August 24, 2007
Study Start
October 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 26, 2015
Record last verified: 2015-11