| Eligibility |
Inclusion Criteria:
1. Good general health by medical history, laboratory findings and physical examination
before receiving vaccination as judged by the investigator (subjects with a minor
controlled illness, such as mild controlled hypertension, asthma or COPD (Chronic
Obstructive Pulmonary Disease), and without fever may be enrolled at the discretion of
the investigator)
2. Subject who is willing and able to comply with the requirements of the protocol (e.g.
completion of the diary cards, return for follow-up visits)
3. Signed written informed consent obtained from the subject
4. For Step 1 Groups 1 and 2 only: Female or male between 18-40 years (inclusive) of age
5. For Step 1 Groups 3 to 6, and Step 2: Female or male subjects between 55-70
(inclusive) years of age at the time of first vaccination
6. Female subjects of childbearing potential are eligible, as long as they practice
adequate contraceptive measures from 2 months before the first vaccination until 1
month after the last vaccination.
Exclusion Criteria:
1. Health condition that, in the opinion of the investigator, may interfere with optimal
participation in the study or place the volunteer at increased risk of adverse events
(AEs) Study clinicians, in consultation with the principal investigator, will use
clinical judgement on a case-by-case basis to assess safety risks under this criterion
2. Any clinically significant deviation from the normal range in biochemistry or
hematology blood tests in the opinion of the investigator
3. Clinically significant abnormalities on physical examination
4. Suspected or known hypersensitivity (including allergy) to any of the vaccine
components or to medicinal products or medical equipment whose use is foreseen in this
study
5. History of allergy to any vaccine
6. Clinical conditions representing a contraindication to intramuscular vaccination and
blood draws (e.g. coagulation disorder)
7. Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal
abnormality diseases and/or insufficiency as determined by physical examination or
laboratory tests. In particular: unstable current or history of coronary artery
disease or cardiac insufficiency, uncontrolled hypertension, clinically significant
history of myocardial infarction, atrial fibrillation, uncontrolled or clinically
significant type 2 diabetes, current or history of rheumatoid arthritis or temporal
arteritis, current acute or chronic active pulmonary diseases.
Note: Subjects may be on chronic or as needed medications if, in the opinion of the
site principal investigator or appropriate sub-investigator, they pose no additional
risk to subject safety or assessment of reactogenicity and immunogenicity and do not
indicate a worsening of medical diagnosis or condition
8. Known or suspected impairment of immunological function, documented Human
Immunodeficiency Virus (HIV) infection, asplenia/splenectomy, or history of autoimmune
disease or lymphoproliferative disorder
9. Positive blood test for HBsAg, HCV (Hepatitis C Virus), HIV-1/2
10. Positive test for SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2)
11. History of systemic administration of immunosuppressive drugs, i.e. corticosteroids,
(PO/IV/IM) within the last 4 weeks prior to 1st vaccination or for more than 14
consecutive days within 3 months prior to 1st vaccination, until the last blood
sampling visit (i.e. prednisone or equivalent =20 mg/day). Inhaled and topical
steroids are allowed.
12. Administration of anti-neoplastic and immune-modulating agents or chemotherapy within
90 days prior to informed consent
13. Planned administration of a vaccine not foreseen by the study protocol within 4 weeks
prior to 1st vaccination and 4 weeks after last vaccination. Vaccination against
seasonal influenza virus (or CoVID (Coronavirus disease) vaccine if on the market) is
allowed outside of +/- 7 days from each vaccination
14. Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational interventional vaccine/product (pharmaceutical product)
15. Body Mass Index (BMI) <19 and >30
16. History of any chronic or progressive disease that according to judgement of the
investigator could interfere with the study outcomes or pose a threat to the
participant's health
17. Received an investigational or non-registered product (medicinal drug or vaccine),
other than the study vaccine within 3 months prior to 1st administration of study
vaccine, or planned use during the study period
18. Administration of immunoglobulin and/or any blood products within the three months
preceding the first dose of study vaccine
19. Blood donation of at least 500 mL blood draw within 3 months preceding injection or
planned during the study period as reported by subject
20. Use of any antibiotic therapy within 1 week preceding each injection
21. Subjects with an elective surgical intervention, planned during the study period until
30 days after 2nd vaccination
22. Females lactating, or pregnancy or intention to become pregnant as reported by subject
23. Current and/or history of chronic alcohol consumption and/or drug abuse
24. History of immune-mediated disease (see Table of pIMDs (potential Immune Mediated
Diseases) in Annex).
25. Heavy smokers (> 20 cigarettes per day)
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