Influenza Vaccination
Conditions
Interventions
Trade Name: InfluJect
Product Name: Inactivated Influenza vaccine (whole virion, Vero Cell derived)
Product Code: n.a
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified, in
Sponsors
Baxter Vaccine AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - are >/= 18 and 60 years old on the day of screening (for Stratum B only); - are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study); -will reliably keep a daily record of symptoms; -understand the nature of the study, agree to its provisions, and give written informed consent prior to study entry; - if female and capable of bearing children – have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study. 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: -have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season; - have received any vaccination within 2 weeks prior to vaccination in this study; - suffer from any kind of immunodeficiency; - suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunologic functions; - have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); - have received a blood transfusion or immunoglobulins within 30 days of study entry; - have donated blood or plasma within 30 days of study entry; -have a history of any vaccine-related contraindicating event (e.g. anaphylaxis, history of allergies to eggs, or other known contraindications); - have a rash or dermatological condition which may interfere with injection site reaction rating; - have a known or suspected problem with drug or alcohol abuse; - are unable to lead an independent life either physically or mentally; - were administered an investigational drug within six weeks prior to study entry; - are concurrently participating in a clinical study including the administration of an investigational product; - if female, are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Assess the immunogenicity of inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination. - Assess the safety of inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination;Secondary Objective: - Compare immune response among three different lots of inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.;Primary end point(s): Primary Immunogenicity Endpoint: The primary immunogenicity endpoint is the number of subjects with seroprotective antibody titer (reciprocal hemagglutination inhibition [HI] antibody titer >/= 40) at Day 21. Primary Safety Endpoint: The primary safety endpoint is the number of subjects with an oral temperature of >/= 38° C within the first 48 hours after vaccination. | — |
Countries
Austria, United Kingdom
Outcome results
None listed