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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
Enrollment
ear-nose-throat (ENT) examination + oesophagoscopy
immunological assessment
Immunization with 4-valent HPV vaccine at 0,2,6 months
Follow up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-valent HPV vaccine | Experimental | 4-valent HPV vaccine administered in months 0., 2., 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-valent HPV vaccine | Biological | Vaccination with 4-valent HPV vaccine in months 0., 2., 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zsofia Meszner, MD, PhD | Contact | +36 1 365 1540 | zmeszner@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zsofia Meszner, MD, PhD | National Institute of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Child Health | Budapest | 1113 | Hungary |
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| ID | Term |
|---|---|
| C535297 | Recurrent respiratory papillomatosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |