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Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00572832
First received: December 11, 2007
Last updated: August 11, 2010
Last verified: August 2010
History of Changes
Results First Received: September 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Human Papillomavirus Infection
Interventions: Biological: Quadrivalent human papillomavirus vaccine on-time administration
Biological: Quadrivalent human papillomavirus vaccine delayed administration

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
6 Month Standard Schedule Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
12 Month Alternative Group 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
Total Total of all reporting groups

Baseline Measures
    6 Month Standard Schedule     12 Month Alternative Group     Total  
Number of Participants  
[units: participants]
 		  100     100     200  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     100     100     200  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  20.3  ± 1.3     20.1  ± 1.4     20.2  ± 1.3  
Gender  
[units: participants]
 		     
Female     100     100     200  
Male     0     0     0  
Race (NIH/OMB)  
[units: Participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     5     2     7  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     8     8     16  
White     83     89     172  
More than one race     0     0     0  
Unknown or Not Reported     4     1     5  
Region of Enrollment  
[units: participants]
 		     
United States     100     100     200  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation 		  24.2  ± 4.7     24.5  ± 5.1     24.3  ± 4.9  



  Outcome Measures

1.  Primary:   Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule   [ Time Frame: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One participant in the Standard group did not respond to any of the vaccine HPV types. Eleven participants in the Alternate group either did not receive Dose 3 or were out of window, compared with only one participant in the Standard group.  


Results Point of Contact:  
Name/Title: Richard Zimmerman
Organization: University of Pittsburgh
phone: 412-383-2354
e-mail: zimmer@pitt.edu


Publications of Results:


Responsible Party: Richard K. Zimmerman, MD/Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00572832     History of Changes
Other Study ID Numbers: 32090
Study First Received: December 11, 2007
Results First Received: September 3, 2009
Last Updated: August 11, 2010
Health Authority: United States: Institutional Review Board