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

NCT01184079 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-03-27

Study results available
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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

Conditions

  • Quadrivalent HPV Vaccine
  • Human Papillomavirus Vaccine

Interventions

BIOLOGICAL

quadrivalent human papillomavirus vaccine

0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months

BIOLOGICAL

quadrivalent human papillomavirus vaccine

0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months

Sponsors & Collaborators

Principal Investigators

  • Richard K Zimmerman, MD MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184079 on ClinicalTrials.gov