Cervical Cancer Clinical Trial
Official title:
Alternate Dosing Schedules Study for HPV Vaccine
To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types
6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response
(geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd
dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing
schedule. This is a prospective observational study of healthy 9-18 year old female patients
receiving either a second or third dose of HPV vaccine as part of their well child care.
Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month
after the third dose of HPV vaccine with the purpose of comparing the immune responses to
HPV vaccine when administered at naturally occurring longer dosing intervals to the immune
response to HPV vaccine when administered as routinely recommended.
Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines
by injection were randomized to receive either the HPV vaccine first or their concomitantly
administered vaccines first. Pain following vaccination was assessed in each arm using the
Faces Pain Scale - Revised.
Please note: This record refers only to the randomized portion of the study where pain
following vaccination was assessed. Please refer to NCT02280642 for the observational
portion of the study.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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