The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.
▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay 1. Proportion of subjects, stratified by group, with seroconversion to HI antibody 2. Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus 3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer * Safety Outcome Measures : 1\. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 21 \~ 6 months)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
592
0.25ml, Intramuscular on Day 0 and 21
0.5ml, Intramuscular on Day 0 and 21
0.5ml, Intramuscular on Day 0 and 21
HI antibody responses after 1 and/or 2 vaccinations
Time frame: 21 days after vaccination
Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination
Time frame: the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination
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0.25ml, Intramuscular on Day 0 and 21
0.5ml, Intramuscular on Day 0 and 21