At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
In Brief
A clinical study evaluating quadrivalent human papillomavirus vaccine for Quadrivalent HPV Vaccine and Human Papillomavirus Vaccine. Completed, enrolled 220 participants across 1 site.
Detailed 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 administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months. Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C): H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin
Study Details
Timeline
Interventions
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months