NCT02280642

Alternate Dosing Schedules Study for HPV Vaccine (ADS)

Alternate Dosing Schedules Study for HPV Vaccine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 331 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 9 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cervical Cancer
• Genital Warts

Interventions

Type	Name	Description
BIOLOGICAL	Both 2nd and 3rd doses on time
BIOLOGICAL	2nd dose late and 3rd dose on time
BIOLOGICAL	2nd dose on time and 3rd dose late
BIOLOGICAL	Both doses late

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2014-10-31
• Last updated: 2014-10-31

Locations

3 sites across 1 country: United States