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Alternate Dosing Schedules Study for HPV Vaccine (ADS)

NCT02280642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 331

Last updated 2014-10-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Emmanuel B Walter, MD · Duke University

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280642 on ClinicalTrials.gov