Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Non-Elderly Adult and Elderly Subjects
|ClinicalTrials.gov Identifier: NCT01356316|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : December 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: AdimFlu-S Vaccine 2010-2011||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2010|
|Primary Completion Date :||August 2010|
|Study Completion Date :||March 2011|
|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
- The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation. [ Time Frame: Change from baseline for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI) at 21 days post immunization ]Twenty-one days after vaccination, serum samples will be taken and tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.
- The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation. [ Time Frame: 7 days after vaccination ]
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.