The effects of BCG-vaccination on the immune response induced by flu-vaccination in healthy volunteers
- Conditions
- Influenza virus infectionMedDRA version: 16.1Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-000966-23-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 72
-Age =18 and =35 yrs or =65 yrs
-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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
-Prior exposure to ‘Influvac’ influenza virus strains , measured by antibody titres. Previous exposure is defined by antibody titres =1:40.
-History of influenza vaccination within the year prior to study entry
-History of BCG vaccination within 5 years prior to study entry
-History of Mantoux testing within the year prior to study entry
-Vaccination other than BCG or influenza, within 3 months prior to study or within study period
-Medical history of any disease associated with immune deficiency
-Clinically significant acute illness, including infections, within 4 weeks before vaccination
-Participation in a drug trial or donation of blood 3 months prior to study entry
-Use of recreational drugs within 21 days prior to experiment day
-Recent hospital admission or surgery with general anaesthesia (<3 months)
-Known chronic kidney or liver disease
-Latent or active tuberculosis infection
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