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Trial record 10 of 15 for:    HPV Merck | received from 01/01/2010 to 12/30/2010
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Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Richard Zimmerman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01184079
First received: August 11, 2010
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Quadrivalent HPV Vaccine
Human Papillomavirus Vaccine
 Biological: quadrivalent human papillomavirus vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Immunogenicity after dose 3 [ Time Frame: 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months) ] [ Designated as safety issue: No ]
    Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups. Also, comparing GMT ratio


Secondary Outcome Measures:
  • preference and compliance with 3rd dose [ Time Frame: at 3rd dose (i.e., at month 6 or month 12, depending on arm) ] [ Designated as safety issue: No ]
    Determine the preference and compliance of the men for the timing of the third dose.

  • Safety profile of third dose [ Time Frame: 1 week after third dose ] [ Designated as safety issue: Yes ]
    Side effect reports after 3rd dose in the 2 groups


Enrollment: 220
Study Start Date: October 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 months
Administration of 3rd dose at 12 months
 Biological: quadrivalent human papillomavirus vaccine
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
Other Name: Gardasil
Active Comparator: 6 month
3rd dose administration at 6 months
 Biological: quadrivalent human papillomavirus vaccine
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Other Name: Gardasil

Detailed Description:

1. Specific Aims and Overview: The investigators propose a randomized, open label trial 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.

Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3.

No cytology studies or DNA studies will be conducted.

1.1 Aims:

  1. Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
  2. Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.
  3. Determine the preference and compliance of the men for the timing of the third dose.

1.2 Hypothesis for non- inferiority:

The GMTs in the 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.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males age 18-26

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184079

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Merck
Investigators
Principal Investigator: Richard K Zimmerman, MD MPH University of Pittsburgh
  More Information

Publications:

Responsible Party: Richard Zimmerman, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01184079     History of Changes
Other Study ID Numbers: IISP#38206, PRO10070407, I#0021806
Study First Received: August 11, 2010
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
human papillomavirus vaccine L1, type 6,11,16,18
HPV Vaccines
HPV L1 vaccine, quadrivalent 6,11,16,18

ClinicalTrials.gov processed this record on May 19, 2013