The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
39
Inactivated whole-virion vaccine 1. Administration route: Intramuscular Injection 2. Dosing schedule: 2 injections - at Day 1 and Day 22 separately 3. Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)
National Cheng Kung University Hospital
Tainan, Taiwan
Immunogenicity Endpoint: hemagglutination inhibition (HAI) titer and microneutralization (MN) titer
The primary immune response endpoint is to evaluate the seroconversion rate (SCR) in terms of HAI assays at Day 43 (21 days after the second dose).The secondary HAI endpoints are defined as following: 1. SCR for the first vaccination, at Day 22. 2. Seroprotection rates (SPR) for each vaccination, at Day 22 and 43. 3. The geometric mean fold rise (GMFR) for each vaccination, at Day 22 and 43. The supportive immunogenicity endpoints of MN antibodies are SCRs, SPRs and GMFRs at Day 22 and 43.
Time frame: At Day 43 (21 days after the second dose).
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 after vaccination.
Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
Time frame: At 4 weeks after two doses of study vaccine, 4 weeks apart. Reactogenicity will be recorded for 7 days after each vaccination.
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