NCT02280642

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

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
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
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

3.5 years

First QC Date

October 29, 2014

Last Update Submit

October 29, 2014

Conditions

Cervical CancerGenital Warts

Keywords

Human papillomavirusCervical cancerGenital wartsVaccineImmunogenicity

Outcome Measures

Primary Outcomes (4)

  • HPV 6 GMT

    Geometric mean titer (GMT) of antibody to HPV type 6

    1 month following 3rd dose of HPV vaccine

  • HPV 11 GMT

    Geometric mean titer (GMT) of antibody to HPV type 11

    1 month following 3rd dose of HPV vaccine

  • HPV 16 GMT

    Geometric mean titer (GMT) of antibody to HPV type 16

    1 month following 3rd dose of HPV vaccine

  • HPV 18 GMT

    Geometric mean titer (GMT) of antibody to HPV type 18

    1 month following 3rd dose of HPV vaccine

Study Arms (4)

Both doses on time

An on time dose 2 was defined as ≥ 30 days to ≤ 90 days after dose 1 and an on time dose 3 was defined as ≥ 60 days to ≤ 180 days after dose 2.

Biological: Both 2nd and 3rd doses on time

Dose 2 delayed

A delayed dose 2 was defined as \> 90 days after dose 1 and an on time dose 3 was defined as ≥ 60 days to ≤ 180 days after dose 2.

Biological: 2nd dose late and 3rd dose on time

Dose 3 delayed

An on time dose 2 was defined as ≥ 30 days to ≤ 90 days after dose 1 and a delayed dose 3 was defined as \>180 days after dose 2.

Biological: 2nd dose on time and 3rd dose late

Both doses delayed

A delayed dose 2 was defined as \> 90 days after dose 1 and a delayed dose 3 was defined as \>180 days after dose 2.

Biological: Both doses late

Interventions

Both 2nd and 3rd doses on timeBIOLOGICAL
Both doses on time
2nd dose late and 3rd dose on timeBIOLOGICAL
Dose 2 delayed
2nd dose on time and 3rd dose lateBIOLOGICAL
Dose 3 delayed
Both doses lateBIOLOGICAL
Both doses delayed

Eligibility Criteria

Age9 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescent females attending primary care clinics in central North Carolina

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

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

Study Officials

  • Emmanuel B Walter, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

March 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

US(3)