Research project which investigates the safety of chickenpox vaccine in patients with cartilage-hair hypoplasia

• Conditions: Cartilage-hair hypoplasia patients.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-000592-27-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-10
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Genetically confirmed cartilage-hair hypoplasia diagnosis, age >12 months, no history of chickenpox, negative serology to varicella zoster virus, CD4+ cell counts = 15% or = 200 cells/mm3, no clinical nor laboratory signs of severe immunodeficiency, informed concent of the patient/caregiver.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
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

Age <12 months, positive serum IgG for varicella zoster virus, low CD4+ cell counts (<15% or <200 cells/mm3), clinical or laboratory signs of severe immunodeficiency, ongoing intravenous or subcutaneous immunoglobulin treatment

Study & Design

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