Status:
COMPLETED
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Quadrivalent HPV Vaccine
Human Papillomavirus Vaccine
Eligibility:
MALE
18-26 years
Phase:
NA
Brief Summary
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administra...
Detailed Description
1\. Specific Aims and Overview: The investigators propose a randomized, open label trial of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed ...
Eligibility Criteria
Inclusion
- Males age 18-26
Exclusion
- Hospitalization within the past year
- Previous HPV vaccination
- \>/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
- History of genital warts
- Immunosuppression
- Other vaccines within 8 days of proposed HPV vaccination
- Hypersensitivity to yeast or HPV vaccine components
- Known autoimmune disorders
- Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
- Serious Adverse Reaction to HPV vaccine
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01184079
Start Date
October 1 2010
End Date
May 1 2012
Last Update
March 27 2014
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261