Human Papillomavirus Infection Clinical Trial
Official title:
Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
Verified date | August 2010 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 23 Years |
Eligibility |
Inclusion Criteria: - 18-23 year old college females who are planning to return to the university for the next fall semester. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Merck Sharp & Dohme Corp. |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
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