The purpose of this study was to determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicited 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 was 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 were 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. In addition, girls receiving a 3rd dose of HPV vaccine as well as 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 observational portion of the study. Please refer to NCT00862810 for the results of the randomized portion of the study.
Study Type
OBSERVATIONAL
Enrollment
331
Chapel Hill Pediatrics
Chapel Hill, North Carolina, United States
Duke Children's Primary Care
Durham, North Carolina, United States
Durham Pediatrics
Durham, North Carolina, United States
HPV 6 GMT
Geometric mean titer (GMT) of antibody to HPV type 6
Time frame: 1 month following 3rd dose of HPV vaccine
HPV 11 GMT
Geometric mean titer (GMT) of antibody to HPV type 11
Time frame: 1 month following 3rd dose of HPV vaccine
HPV 16 GMT
Geometric mean titer (GMT) of antibody to HPV type 16
Time frame: 1 month following 3rd dose of HPV vaccine
HPV 18 GMT
Geometric mean titer (GMT) of antibody to HPV type 18
Time frame: 1 month following 3rd dose of HPV vaccine
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