HPV vaccine for the treatment and prevention of recurrent laryngeal papillomatosis, which is a bening tumor in the upper airways caused by HPV

A Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003049-41-HU

Enrollment

Registered

2013-11-04

Start date

2014-01-27

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrant respiratory papillomatosis

Interventions

Trade Name: SILGARD Product Name: Human papillomavirus vaccine (types 6, 11, 18, 18) Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •minimum 10, max 20, otherwise healthy children, above the first year of life, with minimum 3 relapses of Recurrant Respiratory Papillomatosis could be involved •who underwent ear-nose-throat and oesophagoscopy examination to establish the diagnosis of RRP with or without oesophageal involvement •whose previously removed papillomas were pozitive for HPV 6, or 11, or both •who are able to mount neutralizing antibodies Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •other chronic underlying condition, •other HPV type, •no antibody response

Design outcomes

Primary

Measure	Time frame
Main Objective: •to immunize with the 4-HPV vaccine children with RRP (with at least 3 relapses necessitating surgery) and follow the clinical course for two years after the first dose given •to assess prior and after the third 4-HPV dose certain humoral and cellular immune parameters, virus specific antibodies, INF-gamma, granzyme B tests) •to reduce surgical intervention after vaccination;Secondary Objective: Not applicable;Primary end point(s): Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period;Timepoint(s) of evaluation of this end point: 6th, 12th 18th months after the 3rd vaccine dose	—

Measure

Time frame

Main Objective: •to immunize with the 4-HPV vaccine children with RRP (with at least 3 relapses necessitating surgery) and follow the clinical course for two years after the first dose given •to assess prior and after the third 4-HPV dose certain humoral and cellular immune parameters, virus specific antibodies, INF-gamma, granzyme B tests) •to reduce surgical intervention after vaccination;Secondary Objective: Not applicable;Primary end point(s): Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period;Timepoint(s) of evaluation of this end point: 6th, 12th 18th months after the 3rd vaccine dose

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Hungary

Contacts

Public ContactZsofia Meszner

National Institute of Child Health

zmeszner@gmail.hu3613651540

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026