Effect of vaccination in patients with recurrent respiratory papillomatosis– can we improve the quality of life of these patients?

Phase 1

• Conditions: Recurrent respiratory papillomatosis; MedDRA version: 14.0 Level: PT Classification code 10023849 Term: Laryngeal papilloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002667-14-CZ
• Lead Sponsor: Institute of Hematology and Blood Transfusion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients with RRP which sign the informed consent form with both parts of the study will be enrolled.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients who experience severe side effects of vaccination after the first or second dose will not be vaccinated with the third dose and they will be excluded from the study. Patients who will not receive all three doses within one year and 30 days will be also excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified