NCT01995721

Brief Summary

Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process. After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

November 20, 2013

Last Update Submit

November 20, 2013

Conditions

Recurrent Respiratory Papillomatosis

Keywords

recurrent respiratory papillomatosishuman papillomavirusvaccinetreatmentimmunologyrelapse

Outcome Measures

Primary Outcomes (1)

  • Papilloma relapses

    Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period

    18 months after the 3rd vaccine

Study Arms (1)

4-valent HPV vaccine

EXPERIMENTAL

4-valent HPV vaccine administered in months 0., 2., 6.

Biological: 4-valent HPV vaccine

Interventions

4-valent HPV vaccineBIOLOGICAL

Vaccination with 4-valent HPV vaccine in months 0., 2., 6.

Also known as: Silgard, Gardasil
4-valent HPV vaccine

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • respiratory papillomatosis
  • at least 3 relapses in patient history
  • HPV 6 and/or 11 positive papillomas
  • able to mount neutralizing antibodies

You may not qualify if:

  • other chronic underlying condition
  • other HPV type
  • no antibody response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health

Budapest, 1113, Hungary

Location

MeSH Terms

Conditions

Recurrent respiratory papillomatosisRecurrence

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • Zsofia Meszner, MD, PhD

    National Institute of Child Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zsofia Meszner, MD, PhD

CONTACT

+36 1 365 1540zmeszner@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 27, 2013

Study Start

February 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

HU(1)