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4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

NCT01995721 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-11-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

4-valent HPV vaccine

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

Sponsors & Collaborators

Principal Investigators

  • Zsofia Meszner, MD, PhD · National Institute of Child Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Hungary

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 NCT01995721 on ClinicalTrials.gov