Phase 2
Completed N=150
Study of Gardasil in Mid-Adult Males (MAM)
Source: ClinicalTrials.gov NCT01432574 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of Participants Seropositive at Month 7 — 100; 100; 100; 100 percentage of participants
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] infection in men (HIM) Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Seropositive at Month 7 |
100; 100; 100; 100 | — |
| SECONDARY Change in Antibody Titers |
29.8; 419.5; 40.1; 516.6; 40.1; 2228.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01432574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.