asal administration of palivizumab in an RSV human challenge model
- Conditions
- respiratory syncytial virus infectionTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-004137-21-NL
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
1.Healthy males or females
2.Age 18-55 years
3.Signed and dated informed consent form
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 34
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Child < 3 years old living in subject’s household
2. Person > 65 years old or significant primary or secondary immunodeficiency living in subject’s household
3. Presence of significant acute or chronic medical illness that is associated with increased risk of respiratory viral illness related complications. These include but are not limited to:
a. Recent (within adulthood) history of asthma, chronic obstructive pulmonary disease (COPD), hypertension, reactive airway disease, or any other chronic lung illness
b. History or evidence of impaired immune responsivity or autoimmune disease
c. Confirmed hepatitis B (HBV), human immunodeficiency virus (HIV), or hepatitis C (HCV) infection
4. Adults with a nasal cold or obstructions which could interfere with administration of the study intervention
5. Simultaneous use of other nasal drops, sprays, or medications
6. Nasal surgery prior to or during the trial
7. COVID-19 infection 48 hours before study start
8. Pregnancy
9. Symptoms of clear nasal congestion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method