|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Reactogenicity events are pre-specified adverse events systematically recorded on diary cards(a grid of check boxes for each event and each day) during the immediate post-vaccination period by all participants. In general, reactogenicity events will be recorded for 7 days after vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection.
In regard to the long term safety of the study vaccine, the significant and/or serious adverse event(s) will be recorded during the 6 months follow up after vaccination.
|Study Start Date:||August 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Experimental: AdimFlu-S Influenza Vaccine||
Biological: AdimFlu-S Vaccine 2010-2011
Per ml contains following strains 30μg, A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008