Clinical Trials Directory

Trials / Completed

CompletedNCT00862810

Alternate Dosing Schedules Study for HPV Vaccine

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Duke University · Academic / Other
Sex
Female
Age
9 Years – 18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALReceived HPV vaccine first
BIOLOGICALReceived concomitant vaccines first

Timeline

Start date
2009-03-01
Primary completion
2012-09-01
Completion
2012-09-01
First posted
2009-03-17
Last updated
2014-11-20
Results posted
2014-09-25

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00862810. Inclusion in this directory is not an endorsement.