A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Florida/4/2006-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
Covance Clinical Research Unit AG
Allschwil, Switzerland
Seroconversion
Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Time frame: Day 22 ± 2 days
Seroprotection
Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40
Time frame: Day 22 ± 2 days
Fold Increase in Geometric Mean Titer (GMT)
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Time frame: Day 22/Day 1
Safety: Incidence of Solicited Local Adverse Events
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Time frame: Days 1 to 4 inclusive, and Day 22
Incidence of Solicited Systemic Adverse Events
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Time frame: Days 1 to 4 inclusive, and Day 22
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