Status:
COMPLETED
Study of Gardasil in Mid-Adult Males (MAM)
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Human Papillomavirus
Eligibility:
MALE
27-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effectiveness of the research study vaccine, Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human Papillomavirus \[HPV\] infectio...
Detailed Description
The MAM Study is a prospective pilot intervention trial to investigate patterns of human papillomavirus (HPV) vaccine immunogenicity in men, aged 27-45 years, in which the men will receive Gardasil. G...
Eligibility Criteria
Inclusion
- Men that have completed 4 years of follow-up in the on-going international prospective natural history study of HPV in men (The HIM Study)
- Willing to comply with 4 scheduled visits within a 7-month period
Exclusion
- Have received an HPV vaccine
- Have a prior diagnosis of penile or anal cancers
- Have a prior diagnosis of high grade anal intraepithelial neoplasia
- Have been diagnosed with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
- Have a history of anaphylaxis to vaccines
- Have known impairment of the immune system
- Have received any blood products within 6 months of enrollment
Key Trial Info
Start Date :
February 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01432574
Start Date
February 19 2013
End Date
November 3 2020
Last Update
September 16 2021
Active Locations (2)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
National Institute of Public Health, Mexico
Cuernavaca, Mexico, 62209