Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine

Inclusion Criteria

• Provide written informed consent prior to initiation of any study procedures.
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Are males or non-pregnant females, 18 to 49 years old, inclusive.
• Are in good health*.

*As determined by medical history and targeted physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days prior to investigational vaccine study product administration. This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment and investigational vaccine study product administration. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) 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. Similarly, medication changes subsequent to enrollment and investigational study product vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change. All chronic medical condtions should pose no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.

• Oral temperature is less than 100.0 degrees F.
• Pulse** is 50 to 100 bpm, inclusive.

**Acceptable pulse range prior to IIV4 dose is 45 to 115 bpm, inclusive and no symptoms.

• Systolic blood pressure*** is 85 to 150 mmHg, inclusive. ***Acceptable systolic blood pressure range prior to IIV4 dose is 80 to 155 mm Hg, inclusive and no symptoms.
• Diastolic blood pressure**** is 55 to 95 mmHg, inclusive.

****Acceptable diastolic blood pressure range prior to IIV4 dose is 50 to 100 mm Hg, inclusive and no symptoms.

• Women of childbearing potential* must use an acceptable method of contraception** from 30 days prior to vaccination until 60 days after the second of dose of M-001 or placebo.
• Women of childbearing potential***** must use an acceptable method of contraception****** from 30 days prior to receipt of IIV vaccination, and must plan to use until 28 days after the IIV.

*****Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization with history of documented radiological confirmation test achieved or with use of another approved birth control method if confirmation test not confirmed) and still menstruating or < 1 year of the last menses if menopausal).

******Includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables, contraceptive patches or oral c