Influenza Vaccination in healthy subjects
Conditions
Interventions
Trade Name: InfluJect (The MA for Influject covers the 99/00 product. The vero cell derived Influenza vaccine of season 05/06 contains the strains recom. by the WHO&CPMP and was produced by a mod. pro
Sponsors
Baxter AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects will be eligible for participation in this study if they: Ø Are 18 to 45 years of age, inclusive, on the day of screening; Ø Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; Ø 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); Ø Agree to keep a daily record of symptoms; Ø If female and capable of bearing children – have a negative urine pregnancy test 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in this study if they: Ø Have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season; Ø Have received any vaccination within 2 weeks prior to vaccination in this study; Ø Suffer from any kind of immunodeficiency; Ø Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response; Ø Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); Ø Have received a blood transfusion or immunoglobulins within 30 days of study entry; Ø Have donated blood or plasma within 30 days of study entry; Ø Have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine); Ø Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; Ø Have a known or suspected problem with alcohol or drug abuse; Ø Are unable to lead an independent life as a result of either physical or mental handicap; Ø Were administered an investigational drug within six weeks prior to study entry; Ø Are concurrently participating in a clinical study that includes the administration of an investigational product; Ø If female, are pregnant or lactating; Ø Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Ø Assess the safety of inactivated influenza vaccine (whole virion, Vero cell derived) in comparison to egg derived vaccine. ;Secondary Objective: Ø Assesss the immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived) in comparison to egg derived vaccine. ;Primary end point(s): The primary study endpoint is the number of subjects with temperatures >= 38.0°C and onset within 2 days after vaccination. | — |
Countries
Germany
Outcome results
None listed