| Eligibility |
Inclusion Criteria:
- Written signed informed consent obtained before any study-related activities.
- Aged 18 to 50 years inclusive, at the time of signing the ICF.
- Participants who are considered to be in good general health as determined by medical
evaluation including medical history, physical examination and laboratory tests within
21 days prior to enrollment.
- Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
- Women who are not pregnant or breastfeeding (WOCBP).
- WOCBP must have a negative serum pregnancy test at screening and a negative urine
pregnancy test before vaccination at Day 1.
- Participants who are willing and able to comply with the study procedures and are in
the view of the investigator capable of completing the study.
Exclusion Criteria:
- History of previous laboratory confirmed influenza infection in the past 12 months,
excluding laboratory confirmed COVID-19 infections, prior to the day of study
vaccination.
- Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg),
hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
- Past or current history of immune mediated and/or autoimmune diseases as indicated by
the investigator, e.g. diabetes mellitus (type I or II, with the exception of
gestational diabetes) and thyroid disease.
- Serious reactions to vaccines that preclude receipt of study vaccinations as
determined by the investigator.
- Clinical conditions representing a contraindication for IM administration, as judged
by the investigator, e.g. history of bleeding disorder (e.g. factor deficiency,
coagulopathy, or platelet disorder requiring special precautions) or significant
bruising or bleeding difficulties with IM administration or blood draws.
- History of confirmed hypersensitivity, allergy and/or anaphylaxis to eggs (ovalbumin
or chicken proteins), squalene-based adjuvants, or other components of the study
vaccine (neomycin, formaldehyde or octoxinol-9).
- Current history of uncontrolled medical illness (unstable for the past 3 months) as
indicated by investigator, e.g. hypertension.
- Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and
seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol
withdrawal more than 3 years ago, or 3) seizures that have not required treatment
within the last 3 years.
- History of asplenia, functional asplenia or any condition resulting in the absence or
removal of the spleen.
- Active malignancy or malignancy within the past 5 years.
- Asthma that is unstable or required emergent care, urgent care, hospitalization or
intubation during the past two years or that is expected to require the use of oral or
intravenous corticosteroids.
- History of hereditary angioedema (HAE), acquired angioedema (AAE) or idiopathic forms
of angioedema.
- History of idiopathic urticaria within the past year.
- History of heavy smoking, drug - or alcohol abuse/addiction (including alcohol
dependence), or psychiatric condition (e.g. past or present psychoses; disorder
requiring lithium; or within 5 years prior to administration of study vaccine, a
history of suicide plan or attempt), which in investigator's opinion could compromise
the participant's safety and/or compliance with the protocol.
- A rash, dermatological condition or tattoos that would, in the opinion of the
investigator, interfere with injection local reaction rating.
- Prior seasonal or pandemic influenza vaccination in the 6 months before administration
of study vaccine or planning to receive the influenza vaccination during the study
period.
- Prior receipt of investigational pandemic influenza vaccine in the 3 months before
administration of study vaccine or planning to receive such product during the study
period.
- Prior receipt of a live attenuated vaccine in the 28 days prior to administration of
study vaccine, or within 14 days for subunit or inactivated vaccines other than
seasonal or pandemic influenza vaccination, excluding COVID-19 vaccine.
- Prior receipt of COVID-19 vaccine in the 7 days before administration of study
vaccine, or planning to receive a COVID-19 vaccine during the first 14 days following
study vaccination.
- Planning to receive a vaccine during the first 28 days following the administration of
study vaccine, other than COVID-19 vaccine.
- Currently participating in another clinical study, or planning to participate in
another study during the study period, or administration of any investigational drug
or medical device in the 4 weeks prior to study vaccination.
- Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months
prior to administration of study vaccine, or planning to receipt such product during
the study period.
- Use of drugs that can affect immune response such as systemic corticosteroids
(excluding topical preparations and inhaled preparations) or immunosuppressive drugs
in the 30 days before study vaccination and/or in the first 28 days following study
vaccination, with the exceptions that a short course of corticosteroids =10 days
duration, or a single injection for a self-limited condition at least 2 weeks prior to
enrolment will not exclude study participation.
- Current intake of drugs that increase bleeding risk, e.g. anticoagulant medication
(coumarin derivatives, low molecular weight heparin, DOAC).
- Current anti-tuberculosis prophylaxis or therapy.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or planning a medical
procedure under full anesthesia on the day of study vaccination and/or in the first 14
days following study vaccination with the exception of a medical indication.
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