Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

Completed · Not applicable

Conditions studied: Quadrivalent HPV Vaccine, Human Papillomavirus Vaccine

In brief

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

Key facts

Study ID

NCT01184079

Run by

University of Pittsburgh

People needed

220

Starts

2010-10-01

Expected to finish

2012-05-01

Last updated by the study team

2014-03-27

Who can join

Age: 18 and older, up to 26. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males age 18-26

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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