Bivalent Norovirus Vaccine Study

Inclusion Criteria

Participants must meet all of the inclusion criteria listed below:

• Signed written informed consent.
• 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
• 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.
• Expressed interest and availability to fulfill the study requirements.
• Female participants must be of non-childbearing potential (surgically sterile or post-menopausal for greater than or equal to [>=] 12 months), or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (example oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions for at least 60 days after the last vaccination. A woman is eligible if she is monogamous with a male who has had a vasectomy. Male participants must agree not to father a child for at least 60 days after the last vaccination and to practice abstinence or use an effective method of birth control as noted above.
• 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.
• Agrees to storage of unused clinical specimens for an indefinite period of time for future norovirus research or research on other gastrointestinal pathogens.

Exclusion Criteria

Participants who meet any of the exclusion criteria at baseline will be excluded from study participation. The exclusion criteria are:

• History of any of the following medical illnesses:
• Diabetes
• Cancer (malignancy other than resolved/excised skin lesion)
• Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
• Unconsciousness (other than a single brief "concussion")
• Seizures (other than febrile seizures as a child less than [ ] 140/90 millimeter of mercury [mm Hg] on two separate days)
• 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)
• Positive serology for hepatitis