EUCTR2015-004023-31-NLActive, not recruitingPhase 1
The effects of endotoxin challenge on the immune response elicited by a subsequent challenge with Fluenz™ in healthy volunteers, a pilot study - LPS-FLuenz
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Radboudumc
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •-Age =18 and =35 years of age
- •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
Investigators
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