A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus * 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-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 number 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 number 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: Numbers of Subjects Reporting Solicited Local Adverse Events
Safety assessments are made by the investigator at baseline and on Days 8, 15 and 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 Days 8, 15 and 22
Numbers of Subjects Reporting Solicited Systemic Adverse Events
Safety assessments are made by the investigator at baseline and on Days 8, 15 and 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 Days 8, 15 and 22
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