A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
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
2 other identifiers
interventional
620
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.
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
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
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 29, 2007
CompletedFirst Posted
Study publicly available on registry
October 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJune 8, 2015
June 1, 2015
1.6 years
October 29, 2007
June 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
4 weeks post dose 3
Secondary Outcomes (1)
Seroconversion percentages to HPV types contained in the administered vaccines
4 weeks post dose 3
Study Arms (2)
1
EXPERIMENTALV504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
2
PLACEBO COMPARATORPlacebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Interventions
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
V504 Placebo in 3 dose regimen for 6 month treatment period.
Eligibility Criteria
You may qualify if:
- 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
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 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)
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
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
October 29, 2007
First Posted
October 30, 2007
Study Start
October 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 8, 2015
Record last verified: 2015-06