A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Non-Elderly Adults and Elderly Subjects
This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in non-elderly and elderly subjects. All participates will receive one dose of vaccine (0.5 ml) by intramuscular injection into the upper arm. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events for 28 days, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 28 days after vaccination. Anti-hemagglutinin (HA) antibody titers will be determined using the WHO hemagglutination inhibition reference technique. The central laboratory who is responsible for antibody titrations will not be aware of the background of blood samples (e.g., pre- or post-serum), it is also called observer-blinded. All participates will be followed, either by clinical visit or by telephone contact, for 8 weeks after the vaccination for safety reasons.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
- The primary objective is to evaluate the immune response (i.e. HAI titer) in subjects after administration of influenza vaccine for 2012-2013 season. [ Time Frame: Change from baseline for HAI titer at 21 days post immunization ] [ Designated as safety issue: No ]Serum samples will be obtained prior to vaccination, and 3 weeks post vaccination. Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory.
- Number of participants reporting reactogenicity events [ Time Frame: up to 7 days after vaccination ] [ Designated as safety issue: Yes ]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 including fever (≥38°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions will also be evaluated that include soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
- Number of participants reporting serious and non-serious adverse events [ Time Frame: Up to 8 weeks after vaccination. ] [ Designated as safety issue: Yes ]In regard to the long term safety of the study vaccine, the significant and/or serious/non-serious adverse event(s) will be recorded during the 8 weeks follow up after vaccination.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Contact: Llu Fan||Llu_Fan@adimmune.com.tw|
|National Taiwan University Hospital||Recruiting|
|Principal Investigator: Kuo-Ching Huang, MD|