Immunization of healthy people against influenza H5N1 infection
Conditions
Interventions
Product Name: NIBRG-14 H5N1 vaccine
Product Code: 01-2005
Pharmaceutical Form: Injection*
INN or Proposed INN: vaccinum influenzae inactivatum
Other descriptive name: Influenza A/Viet Nam/1194/2004(H5
Sponsors
OTH - Chief Medical Officer's Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy (immunogenicity) in humans by serology testing of blood taken at day 21-28 after immunization. To assess tolerance/safety (incidence of adverse events).;Secondary Objective: To assess the duration of seropositivity (protective antibody titer) of blood taken at day 80-100, and day 170-180 after immunization.;Primary end point(s): Verification of the fact that in consequence of the vaccination ratio of seroconversion was greater than 30-40% ( in depence of the age category). Verification of the fact that in consequence of the vaccination increase in geometric mean titer was greater than 2-2,5 (in depence of the age category). | — |
Countries
Hungary
Outcome results
None listed