Influenza

To evaluate the safety of AdimFlu-S (QIS) administrated to healthy subjects.

AdimFlu-S (QIS) Influenza Vaccine

0.5

1. Descriptive statistical analysis of proportion of subjects with reactogenicity
events within 7 days after administration of AdimFlu-S (QIS) vaccine.
2. Follow-up for 6 months to evaluate the long term safety of subjects after IP
administration by recording and monitoring adverse events (AEs).

1. Males or non-pregnant females and aged ≥18 years;
2. Willing and able to adhere to visit schedules and all study requirements;
3. Subjects are willing to provide signed study-specific informed consent.

1. Subjects received seasonal influenza vaccine within 6 months prior to study
vaccination;
2. Any known or suspected allergy to any constituent of influenza vaccines
(including but not limited to egg proteins) or a history of severe adverse reaction
to a previous influenza vaccine;
3. Personal history of Guillain-Barré Syndrome;
4. An acute febrile illness within 1 week prior to vaccination;
5. Current upper respiratory illness, including the common cold or
nasal congestion within 72 hours prior to study vaccination;
6. Subjects with influenza-like illness as defined by the presence of fever
(temperature ≥ 38.0°C);
7. Female subjects who are pregnant, lactating or likely to become pregnant during
the study; also women of childbearing potential who disagree to use an
acceptable method of contraception (e.g. hormonal contraceptives, IUD, barrier
device or abstinence) throughout the study;
8. Treatment with an investigational drug or device within 3 months prior to study
vaccination;
9. Subject with other medical history not suitable for vaccination such as fainting
during injection;
10. Underlying condition which in the investigators’ opinion may interfere with
evaluation of the study vaccine or prevents the subject from participating in the
study.