NCT00862810

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

November 20, 2014

Status Verified

September 1, 2014

Enrollment Period

3.5 years

First QC Date

March 15, 2009

Results QC Date

September 17, 2014

Last Update Submit

November 19, 2014

Conditions

Cervical CancerGenital Warts

Keywords

Human papillomavirusCervical cancerGenital wartsVaccineImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Pain Following HPV Vaccine

    Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received. The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

    10 minutes following vaccination

Study Arms (2)

Received HPV vaccine first

OTHER
Biological: Received HPV vaccine first

Received concomitant vaccines first

OTHER
Biological: Received concomitant vaccines first

Interventions

Received HPV vaccine firstBIOLOGICAL
Received HPV vaccine first
Received concomitant vaccines firstBIOLOGICAL
Received concomitant vaccines first

Eligibility Criteria

Age9 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A healthy, medically well female between the ages of 9 - 18 years. (Must be between 9 years and younger than 19 years of age) at time of enrollment
  • Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV vaccine (Group 2 only)
  • For Group 1 - EITHER 1) The second dose of HPV vaccine must not have been administered and it must be within the specified dosing interval for the second dose of HPV vaccine (\> 90 days since the first dose of HPV vaccine) OR 2) The second dose of HPV vaccine must have been administered \> 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose of HPV vaccine (\> 60 days - \< 180 days since the second dose of HPV)
  • For Group 2 - The second dose of HPV vaccine must have been administered \> 30 days and \< 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (\> 180 days since the second dose of HPV)
  • For Group 3 - The second dose of HPV vaccine must have been administered \> 30 days and \< 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (\> 60 days - \< 180 days since the second dose of HPV)
  • For Group 4- The second dose of HPV vaccine must have been administered \> 90 days after the first dose of HPV of HPV vaccine and it must be within the specified dosing interval for the third dose (\> 180 days since the second dose of HPV)
  • Ability and willingness to participate in the study by providing written informed assent. Verbal assent is acceptable for subjects less than 12 years of age.
  • Parent/guardian provides informed consent
  • Anticipated ability and willingness to complete all study visits and evaluations

You may not qualify if:

  • Unable to comply with the study protocol
  • Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine outside the pre-specified time windows
  • Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period
  • Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks of receipt of the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine
  • History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements
  • History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection
  • Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months prior to HPV vaccine dose 1 and enrollment or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids are any parenteral corticosteroid, high dose (\>800 mcg/day) beclomethasone dipropionate or equivalent medication. Nasal and topical steroids are allowed.
  • Current or former participation in HPV vaccine related research.
  • Receipt of an investigational or alternate HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chapel Hill Pediatrics

Chapel Hill, North Carolina, 27514, United States

Location

Duke Children's Primary Care

Durham, North Carolina, 27704, United States

Location

Durham Pediatrics

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCondylomata Acuminata

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPapillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Emmanuel Walter MD, MPH
Organization
Duke University Health System
walte002@mc.duke.edu
919-620-5346

Study Officials

  • Emmanuel B Walter, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 20, 2014

Results First Posted

September 25, 2014

Record last verified: 2014-09

Locations

US(3)