A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects
Condition: Pandemic Influenza Prevention
Intervention: BLB-750 Vaccine (Qinghai RG strain)
Intervention description: BLB-750 Injection
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 20 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular
      vaccinations with BLB-750 in healthy Japanese adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant signs and dates a written, informed consent form prior to the
             initiation of any study procedures.

          3. The participant is a healthy Japanese adult man or woman.

          4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent.

          5. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent throughout the duration of the study.

        Exclusion Criteria:

          1. The participant has received vaccination with any other investigational products
             within 4 months prior to vaccination with the study drug.

          2. The participant has a history of vaccination with an H5N1 influenza vaccine.

          3. The participant has a history of infection with H5N1 virus.

          4. The participant is at high risk of contracting H5N1 influenza infection (e.g., poultry
             workers).

          5. The participant is an immediate family member, study site employee, or is in a
             dependant relationship with a study site employee who is involved in conduct of this
             study (e.g., spouse, parent, child, sibling) or may consent under duress.

          6. The participant has poorly controlled, clinically significant manifestations of
             neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal,
             urologic, endocrine, or other disorders, which may impact their ability to participate
             as participants or may potentially confound the study results.

          7. The participant has a body temperature (oral) ≥37.5°C prior to vaccination with the
             study drug on Day 1.

          8. The participant has any medically diagnosed or suspected immune-deficiency condition.

          9. The participant has an immunocompromising condition or disease, or is currently
             undergoing a form of treatment or was undergoing a form of treatment that can be
             expected to influence immune response within 30 days prior to vaccination with the
             study drug.

             Such treatments include, but are not limited to, systemic or high dose inhaled
             corticosteroids (>800 μg/day of beclomethasone dipropionate or equivalent; the use of
             inhaled and nasal steroids that do not exceed this level will be permitted), radiation
             treatment or other immunosuppressive or cytotoxic drugs.

         10. The participant has received antipyretics within 4 hours prior to vaccination with the
             study drug.

         11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders
             (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis), or
             convulsions.

         12. The participant has a functional or anatomic asplenia.

         13. The participant has a rash, other dermatologic conditions or tattoos that may
             interfere with the evaluation of local reaction.

         14. The participant has a past or present history of infection with the Hepatitis B Virus
             (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).

         15. The participant has a known hypersensitivity to any component of BLB-750.

         16. The participant has a history of severe allergic reactions or anaphylaxis.

         17. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol dependence within 1 year prior to vaccination with the study drug
             or is unwilling to agree to abstain from excessive alcohol and drugs throughout the
             study.

         18. The participant has received any blood product (e.g., blood transfusion or
             immunoglobulin) within 90 days prior to vaccination with the study drug.

         19. The participant has received any live vaccine within 4 weeks (28 days) prior to
             vaccination with the study drug or any inactivated vaccine within 2 weeks (14 days)
             prior to vaccination with the study drug.

         20. The participant is a pregnant or lactating woman or wishes to become pregnant before
             signing informed consent, during, or within 12 weeks after the last vaccination with
             the study drug or intends to donate ova during such time period.

         21. For males: The participant has donated whole blood ≥200 mL within 4 weeks (28 days) or
             ≥400 mL within 12 weeks (84 days) prior to the first vaccination with the study drug.

             For females: The participant has donated whole blood ≥200 mL within 4 weeks (28 days)
             or ≥400 mL within 16 weeks (112 days) prior to the first vaccination with the study
             drug.

         22. For males: The participant has donated whole blood ≥800 mL in total within 52 weeks
             (364 days) prior to the first vaccination with the study drug.

             For females: The participant has donated whole blood ≥400 mL in total within 52 weeks
             (364 days) prior to the first vaccination with the study drug.

         23. The participant has donated blood components within 2 weeks (14 days) prior to the
             first vaccination with the study drug.

         24. In the opinion of the investigator, the participant is unlikely to comply with
             protocol requirements or is considered ineligible for any other reason.

         25. The participant has presence of thrombocytopenia or coagulopathy, or has received
             anticoagulant therapy within 30 days prior to the first vaccination with the study
             drug.