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Clinical Trials/EUCTR2013-003049-41-HU
EUCTR2013-003049-41-HU
Active, not recruiting
Not Applicable

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

ational Institute of Child Health0 sitesNovember 4, 2013
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ConditionsRecurrant respiratory papillomatosisTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
DrugsSILGARD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrant respiratory papillomatosis
Sponsor
ational Institute of Child Health
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 4, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ational Institute of Child Health

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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