H3N2 M2SR in Pediatric Population

Inclusion Criteria

• Parent(s)/legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject must provide assent.
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Are males or non-pregnant females, 9-17 years old, inclusive at the time of enrollment.
• Are in good health*.

*As determined by medical history and 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 (no hospitalizations, ER, or urgent care for condition and no adverse symptoms that need medical intervention). 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. 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 study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Low dose topical steroids, herbals, vitamins, and supplements are permitted.

• Oral temperature is less than 100.0 degrees Fahrenheit.
• For female adolescent of child-bearing potential* must agree to correctly use an acceptable method of contraception** from 30 days prior to vaccination until 30 days after the last study vaccination.

*Defined by the onset of menses, and not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating.

**Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, and correct use of male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables, contraceptive patches or oral contraceptives ("the pill"). Method of contraception will be captured on the appropriate data collection form.

• Female adolescent of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination.
• Males who are sexually active with a female of childbearing potential must agree not to father a child for 30 days after receipt of the first study vaccination.
• Agrees not to participate in another clinical trial during the study period.
• Agrees not to donate blood or blood products to a blood bank for 12 months after receiving the investigational vaccine.
• Weight = / > 34 kg or 75 pounds.
• Hemoglobin = / > 11.5 g/dL.
• Hematocrit > 35%.
• Ferritin level = / > 15 ng/mL.
• Parent/legal guardian must provide consent to future use of stored samples.