Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
1 other identifier
interventional
200
1 country
1
Brief Summary
This is a randomized, open label trial of HPV (human papilloma virus) vaccine, 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 vaccine at 6 months or vaccine at 12 months. Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
February 25, 2010
CompletedAugust 17, 2010
August 1, 2010
1.6 years
December 11, 2007
September 3, 2009
August 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule
Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.
1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)
Study Arms (2)
6 mon. 3rd dose of quadrivalent human papillomavirus vaccine
ACTIVE COMPARATORReceipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
12 mon. 3rd dose of quadrivalent human papillomavirus vaccine
ACTIVE COMPARATORReceipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.
Interventions
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
Eligibility Criteria
You may qualify if:
- year old college females who are planning to return to the university for the next fall semester.
You may not qualify if:
- Pregnancy or planned pregnancy.
- Prior receipt of HPV vaccine.
- Greater than four lifetime sexual partners.
- Immunosuppression.
- Anti-coagulant therapy.
- Breastfeeding.
- History of abnormal pap smear.
- Allergy to vaccine components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753.
PMID: 20629576RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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
- Title
- Richard Zimmerman
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Richard K. Zimmerman, MD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2009
Study Completion
August 1, 2009
Last Updated
August 17, 2010
Results First Posted
February 25, 2010
Record last verified: 2010-08