Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants
Condition: Influenza Infection
MeSH terms: Influenza, Human
Intervention: TAK-850; Influenza HA vaccine
Intervention description: TAK-850 subcutaneous injection; Influenza HA vaccine subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 20 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of TAK-850
      administered subcutaneously as a single dose versus influenza HA vaccination in an
      exploratory manner.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or subinvestigator, 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 male or female.

          4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent.

          5. The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m^2, inclusive,
             at the time of the eligibility evaluation.

          6. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agreed to routinely use adequate contraception from signing
             of the informed consent throughout the duration of the study.

        Exclusion Criteria:

          1. The participant has received any investigational compound within 4 months prior to
             injection of study vaccine.

          2. The participant has been vaccinated with seasonal influenza vaccine within 6 months
             prior to injection of study vaccine.

          3. The participant has a history of influenza infection within 6 months prior to
             injection of study vaccine.

          4. The participant has been vaccinated with TAK-850 before.

          5. The participant is a study site employee, an immediate family member of such an
             employee, or in a dependent relationship with a study site employee who is involved in
             the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under
             duress.

          6. The participant has uncontrolled, clinically significant manifestations of
             neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal,
             urologic, endocrine, or other disorders, which may impact the ability of the
             participant to participate or potentially confound the study results.

          7. The participant has an oral temperature >= 37.5 °C prior to injection of study vaccine
             on Day 1.

          8. The participant has any medically diagnosed or suspected immune deficient condition.

          9. The participant has an immune compromising 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 injection of study
             vaccine. Such treatments include 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 therapy, and
             other immunosuppressive and cytotoxic drugs.

         10. The participant has received antipyretics within 4 hours prior to the injection of
             study vaccine.

         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 surgical asplenia.

         13. The participant has a rash, other dermatologic conditions, or tattoos which may
             interfere with the evaluation of injection site reaction.

         14. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs),
             Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).

         15. The participant has known hypersensitivity to any component of TAK-850 or Influenza HA
             Vaccine.

         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 abuse within 1 year prior to injection of study vaccine or is
             unwilling to agree to abstain from excessive alcohol and drugs throughout the study.

         18. The participant has received any blood products (blood transfusion or immunoglobulin)
             within 90 days prior to injection of study vaccine.

         19. The participant has received a live vaccine within 4 weeks (28 days) or an inactivated
             vaccine within 2 weeks (14 days) prior to injection of study vaccine.

         20. If female, the participant is pregnant or lactating or intending to become pregnant
             before signing of informed consent, during treatment, or within 12 weeks after
             injection of study vaccine; or intending to donate ova during this time period.

         21. The participant has donated whole blood >= 200 mL within 4 weeks (28 days), >= 400 mL
             within 12 weeks (84 days), >= 800 mL within 52 weeks (364 days) or blood components
             within 2 weeks (14 days) prior to injection of study vaccine.

         22. The participant has abnormal laboratory values that suggest a clinically significant
             underlying disease at the assessment prior to the injection of study vaccine, or the
             participant has the following laboratory abnormalities: alanine aminotransferase (ALT)
             and/or aspartate aminotransferase (AST) more than 3 times the respective upper limits
             of normal.

         23. In the opinion of the investigator or subinvestigator, the participant is unlikely to
             comply with protocol requirements or is considered ineligible for any other reasons.