Efficacy and safety of an shortened outpatient vaccination scheme fortherapy with insect poiso

Phase 1

• Conditions: Immunotherapy against systemic anaphylactic sting reactions; MedDRA version: 21.1Level: PTClassification code 10001749Term: Allergy to stingSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-002769-44-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Legally competent male and female subjects with a history of systemic anaphylactic sting reaction (= grade I according to the classification of Ring and Messmer)
Age =18 and =70 years
Written consent of the participant after being informed
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

Simultaneous participation in another clinical trial
Nursing women

Absolute contraindication(s) for VIT:
- Uncontrolled Asthma
- Autoimmune disorders in active forms (nonresponding to treatment)
- Pregnancy
- AIDS
· Pretreatment with Omalizumab

Study & Design

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