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

Completed · Not applicable

Conditions studied: Human Papillomavirus Infection

In brief

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.

Key facts

Study ID

NCT00572832

Run by

University of Pittsburgh

People needed

200

Starts

2007-09-01

Expected to finish

2009-08-01

Last updated by the study team

2010-08-17

Who can join

Age: 18 and older, up to 23. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18-23 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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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