Influenza Virus

Primary objectives:  To evaluate the immunogenicity of AdimFlu-A (H7N9) at Day 43 by – Seroprotection rate (SPR) – Seroconversion rate (SCR) – Geometric mean increase (GMI) – And/or neutralizing antibody titer Secondary objectives:  To evaluate the safety of AdimFlu-A(H7N9) by, – Solicited and unsolicited adverse events (Day 1~Day 7 and Day 22~Day 28) – Adverse events of interest and serious adverse events (21 days after each vaccination and 180 days after second vaccination) – Changes in laboratory values (hematology and biochemistry, Day 22 vs. baseline and Day 43 vs. baseline). – Compare the safety profile between active and placebo group.  To evaluate the immunogenicity of AdimFlu-A (H7N9) vaccine by – The seroconversion rate, seroprotection rate and geometric mean increase at 21 days after each vaccinations and 180 days after the second vaccination by HAI assay. – The seroconversion rate, seroprotection rate and geometric mean increase at 21 days after each vaccinations and 180 days after the second vaccination by MN assay.

AdimFlu-A (H7N9) vaccine

Each dose (0.5 mL) contained 30 μg purified influenza A (H7N9) virus antigen adjuvanted with 150 μg aluminum hydroxide.

Suspension, 0.5 mL sterile suspension/dose for each injection.

Each dose (0.5 mL) contained 30 μg purified influenza A (H7N9) virus antigen adjuvanted with 150 μg aluminum hydroxide.

Primary Endpoints
Sufficient post-vaccination immunogenicity at Day 43, as defined by achieving either one of the
two criteria:
(1) ALL of the following assessments meet the indicated requirements by HAI assay:
 Seroconversion rate (SCR) >40%
 SCR: percentage of subjects achieving either a pre-vaccination HAI titer <1:10 and
a post-vaccination HAI titer ≥1:40 OR a pre-vaccination HAI titer ≥1:10 and a
minimum 4-fold increase in post-vaccination HAI titer
 Geometric mean increase (GMI) >2.5-fold
 Seroprotection rate (SPR) >70%
 SPR: percentage of subjects achieving HAI titer ≥1:40 or MN titer ≥1:20
(2) One or two of the following assessments meet the indicated requirements by HAI assay;
combined with at least one of the following assessments meet the indicated requirements by
MN assay:
 Seroconversion rate (SCR) >40%
 SCR: percentage of subjects achieving either a pre-vaccination HAI titer <1:10 and
a post-vaccination HAI titer ≥1:40 OR a pre-vaccination HAI titer ≥1:10 and a
minimum 4-fold increase in post-vaccination HAI titer OR a minimum 4-fold increase
in MN titer
 Geometric mean increase (GMI) >2.5-fold
 Seroprotection rate (SPR)  >70%
 SPR: percentage of subjects achieving HAI titer ≥1:40 or MN titer ≥1:20
Secondary Endpoints
1. The percentage, and severity of local and systemic solicited adverse events and unsolicited
adverse events within 7 days after each vaccination (Day 1 ~ Day 7 and Day 22 ~ Day 28).
2. The percentage, severity, and relationship to study vaccination of unsolicited adverse events
and serious adverse events within 21 days after each vaccination (Day 1 ~ Day 22 and Day 22
~ Day 43).
3. Percentage of subjects with clinically significant laboratory changes at 3 weeks after each
vaccination (Day 22 and Day 43).
4. The percentage, severity, and relationship to study vaccination of serious adverse event and
adverse event of special interest during the post-vaccination follow up period (Day 43~Day
202).
5. Other immunogenicity endpoint includes the immunogenicity profile (including SCR, SPR
and GMI) at 21 days after first vaccination and at 180 days after the second vaccination.

Main inclusion criteria (subjects who meet ALL inclusion criteria will be included):
(1) Males or non-pregnant females, age ≥ 18 and ≤ 60 years old.
(2) Subjects who are physically and mentally capable of participating the study and are
willing to adhere to study procedures.
(3) Subjects who are in good physical health (as established by medical history and
physical examination based on the Investigator’s clinical judgment).
(4) Subjects who provide informed consent after receiving a detailed explanation of study
procedures.

Main exclusion criteria (subjects who meet ANY exclusion criteria will be excluded):
(1) Receipt of influenza vaccine within the past 6 months.
(2) Receipt of live virus vaccine within 1 month prior to Screening visit or expected receipt
within 2 months after Screening visit.
(3) Receipt of any inactivated virus vaccine within 2 weeks prior to Screening visit or
expected to receive within 2 weeks after the second study vaccination.
(4) Subjects with hypersensitivity to eggs or egg protein products.
(5) Subjects with personal or family history of Guillain-Barré Syndrome.
(6) Subjects with influenza-like illness as defined by the presence of fever (body
temperature ≥38˚C) and at least two of the following four symptoms: headache,
muscle/joint aches and pains (e.g., myalgia/arthralgia), sore throat, and cough at the
time of planned study vaccinations.
(7) Female subjects of child bearing potential who disagree to practice medically
recognized birth control methods throughout the study (from Screening to the second
vaccination) or female subjects who are pregnant or lactating.
(8) Treatment with an investigational drug or device or participation in a clinical study
within 3 months prior to Screening visit.
(9) Subjects who had ever receive H7N9 vaccine.
(10) Subjects with any confirmed or suspected abnormal immune function,
immunosuppressive, or immunodeficiency.
(11) Subjects with history of wheezing or have been using bronchodilator within 3 months
prior to Screening visit.
(12) Receipt of any blood products, including immunoglobulin within 3 months before
Screening visit.
(13) Subjects who are not suitable (as judged by the Investigators) to participate in this trial.