Safety and immunogenecity of NIBRG-14 H5N1 01-2005 mock-up vaccine for potencial pandemic vaccine producers in Hungary - H5N1 01-2005 mock-up vaccine
- Conditions
- Immunization of healthy people against influenza H5N1 infection
- Registration Number
- EUCTR2005-004153-10-HU
- Lead Sponsor
- OTH - Chief Medical Officer's Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Healthy adult volunteers, aged over 18 years, both sexes.
Negative pregnancy test for women of childbearing potential.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Definitive immunodeficiency; history of Guillain-Barré syndrome; severe concomitant disease; use of immunosuppressive medication; use of inactivated vaccine 14 days prior to vaccination; use of live, attenuated vaccine within 60 days of the study; acute febrile illness on the day of vaccination; pregnant or nursing women; known allergies to any component of the vaccine; history of allergy to eggs or egg products;
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