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NCT01432574 · ClinicalTrials.gov registry record · Phase 2
Study of Gardasil in Mid-Adult Males (MAM)
A Phase 2 study of Human Papilloma Virus, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT01432574: Completed Phase 2 study of Human Papilloma Virus, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01432574 is a Phase 2 study of Human Papilloma Virus that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 150 participants, below the 8,437-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01432574, a Phase 2 study of Human Papilloma Virus, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine
Conditions Studied
Interventions
- BIOLOGICAL Gardasil
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Other
- National Institute of Public Health, Mexico - Cuernavaca
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-02-19 |
| Est. Completion | 2020-11-03 |
| Phase | Phase 2 |
What the finished NCT01432574 record still lists
NCT01432574 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 8,437-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Human Papilloma Virus appearing as the primary indexed condition, and to 1 intervention - of which Gardasil is the first listed.
NCT01432574 reports a single indexed study location in Florida, Other.
Frequently Asked Questions
What is clinical trial NCT01432574 about?
NCT01432574 is a clinical study titled "Study of Gardasil in Mid-Adult Males (MAM)". 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.
What is the current status of trial NCT01432574?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2013-02-19. Estimated completion is 2020-11-03.
What conditions does trial NCT01432574 study?
This clinical trial studies the following conditions: Human Papilloma Virus.
What interventions are being tested in trial NCT01432574?
The interventions under investigation include: Gardasil (BIOLOGICAL).
Who is sponsoring clinical trial NCT01432574?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01432574 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01432574's enrollment target sits among peer trials
150 21st of 39 higher than 17 of 39 other Human Papilloma Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papilloma Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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