A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Healthy Subjects Aged Over 3 Years Old to 18 Years Old
This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged equal to or over 3 years old and less than 9 years old will received two doses of vaccine (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days). Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events observed since first vaccination to 28 days after the last dose of vaccination, and serious adverse events during the observation. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each 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 subjects will be followed, either by clinical visit or by telephone contact, for 8 weeks after the last 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 immunogenicity profiles for influenza virus vaccine strains (2012-2013 season) of the AdimFlu-V. [ Time Frame: Change from baseline for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI) at 28 days post immunization ] [ Designated as safety issue: No ]Serum samples will be obtained prior to vaccination, and 4 weeks post each 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. Subjects will be considered to be seronegative if serum HAI titer < 1:10. The seroconversion is defined as the post-vaccination serum HAI titer at least 1:40 for whom had negative pre-vaccination or a four-fold 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-V. [ Time Frame: 7 days of each vaccination and 8 weeks after last 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 each 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.
In regard to the long term safety of the study vaccine, the significant and/or serious adverse event(s) will be recorded during the 8 weeks follow up after the scheduled last vaccination.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Contact: Llu Fan||Llu_Fan@adimmune.com.tw|
|Chang Gung Memorial Hospital at Linkuo||Recruiting|
|Taoyuan County, Taiwan|
|Contact: YH Hsiao +886-3-3196200|
|Principal Investigator: Yu-Cheng Huang|