Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
135
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle
Betriebsaerztlicher Dienst, Standort Marburg
Baldingerstrasse, Marburg Hessen, Germany
Z29, Blutspendezentrale, Gebaude Z29, Behringwerke
Emil-von-Behring-Str. 76, Marburg, Germany
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Time frame: 3 weeks postvaccination (Day 22)
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
Time frame: 3 weeks postvaccination (Day 22)
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70% for adults and \>60% for elderly subjects.
Time frame: 3 weeks postvaccination (Day 22)
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Proportion of subjects with either seroconversion (antibody increase from \< 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination). According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be \>40% for adults and \>30% for elderly subjects.
Time frame: 3 weeks postvaccination (Day 22)
Number of Subjects Reporting Local and Systemic Reactions
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To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.
Time frame: 3 days postvaccination