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Table 1 Trial inclusion and exclusion criteria trial subjects

From: Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial

Inclusion criteria - Aged between 18 and 60 years
- Healthy males and healthy non-pregnant females (as indicated by a negative blood pregnancy test during the screening visit)
- Healthy as determined by vital signs (heart rate, blood pressure, oral temperature), blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), medical history, general physical examination, self-reported illness and the clinical judgment of the investigator
- Women of childbearing potential (not surgically sterile or postmenopausal for ≥1 year) and men must agree to practice adequate contraception (a combination of barrier and hormone methods for women and a condom for men) throughout the study treatment for at least up 30 days (to day 51 for females) and 90 days (to 111 for males) after the last vaccination
- Able to understand and comply with planned study procedures
- Provides signed informed consent form after receiving a detailed explanation of the study protocol prior to any study procedures
Exclusion criteria - Known allergy to any of the components of the vaccine
- History of severe reactions following immunization
- Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy
- Positive pregnancy test during the screening visit or who are breastfeeding
- History of (reported by subjects):
Acute disseminated encephalomyelitis (ADEM);
Neoplastic disease – current or previous;
Asthma or severe allergic disease;
Bleeding disorders;
Chronic hepatitis B and/or C infection;
Chronic liver disease;
Diabetes mellitus;
Guillain-Barre syndrome;
Human immunodeficiency virus (HIV);
Rheumatoid arthritis or other autoimmune diseases;
Severe renal disease;
Transplant recipients;
Unstable or progressive neurological disorders
- Receipt of medicines/treatment that may affect the evaluation of immunogenicity such as;
Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (within the 6 months prior to vaccination in this study);
Immunoglobulin or other blood products (within the 3 months prior to vaccination in this study);
Experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent during the study period;
Influenza antiviral medication within the 4 weeks prior to the vaccination in this study.
- Received any influenza vaccine within 6 months prior to vaccination in this study.
- Influenza like-illness (a sudden onset of symptoms and at least one of the four systemic symptoms fever, or feverishness, malaise, headache, myalgia and at least one of the three respiratory symptoms cough, sore throat, shortness of breath) or acute respiratory infection (a sudden onset of symptoms and at least of the four respiratory symptoms cough, sore throat, shortness of breath, coryza and a clinician’s judgment that the illness is due to an infection) within 6 months prior to vaccination in this study. These symptoms must have stopped the subject from carrying out their normal daily activities such as attending work or school for a period of at least 3 days.
- Acute illness, including an oral temperature greater than 38 °C, within 1 week before vaccination.
- History of alcohol or drug abuse within the last 2 years deemed unsuitable for inclusion by the investigator.
- Any abnormal haematology values and/or serum chemistries judged by the investigator as clinically significant.
- Ineligible subject based on the judgement of the investigator.
In case there is uncertainty about the participant’s medical status regarding any of the exclusion criteria mentioned, the participant’s primary care physician will be consulted. Consultation of the primary care physician will only take place after having received written approval from the participant, and will concern medical information about exclusion criteria only.