Het effect van het influenza-vaccin Fluenz”, op de onderdrukking van het afweersysteem dat optreedt bij bloedvergiftiging

Phase 1

• Conditions: Inflammatory conditions in general and immunosuppressive conditions is particular; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-004023-31-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-04
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

-Age =18 and =35 years of age
-Male
-Healthy

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pre-existent lung disease, including asthma
-A history of allergic rhinitis
-Use of any medication
-Current smoker or more than 5 pack-year history
-Use of recreational drugs within 21 days prior to start of the study
-Use of caffeine or alcohol within 1 day prior to start of the study
-Surgery or trauma with significant blood loss or blood donation within 3 months prior to start of the study
-Participation in another clinical trial within 3 months prior to start of the study
-Frequent nosebleeds
-Recent nasal or otologic surgery
-Clinically significant acute (febrile) illness or a common cold within four weeks prior to start of the study
-History of frequent vaso-vagal collapse or of orthostatic hypotension History, signs or symptoms of cardiovascular disease.
-History of allergic reaction to Fluenz™, eggs / gelatin / gentamicin
-History of Guillain-Barré Syndrome
- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a
complex bundle branch block.
-Hypertension (defined as RR systolic > 160 or RR diastolic > 90).
-Hypotension (defined as RR systolic < 100 or RR diastolic < 50).
-Renal impairment (defined as plasma creatinin >120 µmol/l).
-Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L
-CRP > 20 mg/L, WBC > 12x109/L

Study & Design

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