Bivalent Norovirus Vaccine Study

Inclusion Criteria

• •1. Signed written informed consent.
• •2. Age:
• •* Cohort A: 18-49 years, inclusive
• •* Cohort B: 50-64 years, inclusive
• •* Cohort C: 65-85 years, inclusive
• •* Cohort D: 18-49 years, inclusive
• •3. Health Status:
• •* Cohort A and D: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control.
• •* Cohorts B and C: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control. Any existing medical diagnoses or conditions must be stable based on medical history and targeted physical examination. A stable medical condition is defined as: (A) Clinically acceptable health outcomes for the specific condition over the prior 6 months and (B) No change in prescription medication(s), dose, or frequency over the prior 3 months. Acceptable changes in medications are: a change of health care provider or insurance company or that is made for financial reasons as long as the medications are in the same class and/or a change due to improvement in a disease outcome.
• •4. Expressed interest and availability to fulfill the study requirements.
• •6. Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study one year after the last study dose that is 393 days.
• •7. Agrees to storage of unused clinical specimens for an indefinite period of time for future norovirus research or research on other gastrointestinal pathogens.
• •3. Allergies or hypersensitivity to any component of the vaccine including MPL and Al(OH)3 adjuvants.
• •4. Any clinically significant abnormality detected on physical examination, including:
• •* Murmur (other than a functional murmur)
• •* Focal neurological abnormality
• •* Hepatosplenomegaly
• •* Lymphadenopathy
• •* Jaundice
• •5. Hypertension (Blood Pressure \[BP\] greater than \[\>\] 140/90 millimeter of mercury \[mm Hg\] on two separate days)
• •6. Any lab abnormality (per the site local laboratory), as listed below:
• •* Absolute Neutrophil Count (ANC) outside the normal range (may be repeated if outside this limit)
• •* Total white blood cells (WBC) outside the normal range (may be repeated if outside this limit)
• •* Hemoglobin outside the normal range (may be repeated if outside this limit)
• •* Platelet count outside the normal range (may be repeated if outside this limit)
• •* Blood urea nitrogen (BUN) \> upper limit of normal (ULN) (may be repeated if outside this limit)
• •* Creatinine \> ULN (may be repeated if outside this limit)
• •* Glucose (fasting or random) outside the normal range (may be repeated if outside this limit)
• •* Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \> ULN (may be repeated if outside this limit)
• •7. Positive serology for hepatitis C or Human Immunodeficiency Virus (HIV) antibody or hepatitis B surface antigen.
• •8. For women of child bearing potential, positive serum pregnancy test within 14 days and urine pregnancy test within 24 hours of administering either dose of IM Norovirus Bivalent VLP Vaccine or control.
• •9. Nursing mother.
• •10. Temperature \>100.4 degree Fahrenheit (F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days of administration of IM Norovirus Bivalent VLP Vaccine or control.
• •11. Previous participation in a Norovirus vaccine or challenge study.
• •12. Study site personnel or their family members.
• •13. Significant history of psychiatric hospitalization, alcohol abuse, or illicit drug use in the prior 5 years.
• •14. Completion of an investigational vaccine or drug study within 28 days before administration of IM Norovirus Bivalent VLP Vaccine or control.
• •15. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
• •16. Other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a participant participating in the trial, would render the participant unable to comply with the protocol or would interfere with the evaluation of the vaccine.