VXA-G1.1-NN

NVG is a composite endpoint defined as meeting both the definition of AGE and NV. AGE was defined as meeting any one of 3 criteria (diarrhea, vomiting, or diarrhea and vomiting) in any 24-hr rolling period. The individual criteria for diarrhea, vomiting, or diarrhea and vomiting were as follows: 1\. Diarrhea: i. ≥ 3 loose or liquid stools in any 24-hr rolling period, or ii. 400 g of loose or liquid stools in any 24-hr rolling period 2. Vomiting: ≥ 2 vomiting episodes in any 24-hr rolling period, or 3. Diarrhea and vomiting: i. one vomiting episode plus any loose or liquid stool in any 24-hr rolling period ii. one vomiting episode plus ≥ 2 of the following events in any 24-hr rolling period: 1. nausea 2. fever (oral temperature ≥ 37.6°C) 3. abdominal cramps or pains 4. abdominal gurgling or bloating 5. myalgia NV infection was defined as having 1 or more positive results in stool or urine by quantitative real time reverse transcription polymerase chain reaction (qRT-PCR).

Blood samples were collected at different timepoints throughout the study.

Blood samples were collected at different timepoints throughout the study. A positive change indicates an increase in titers.

Blood samples were collected at different timepoints throughout the study.

Blood samples were collected at different timepoints throughout the study.

Comparison of VPI specific immunoglobin A (IgA) ASC levels between the 3 study cohorts by enzyme-linked immunospot (ELISpot) assay

Comparison of subjects with a ≥2-, 3- or 4-fold increase over baseline titer of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts.

Comparison of VPI specific immunoglobin A (IgA) ASC levels by Mesoscale Discovery (MSD) assay between the 3 study cohorts

Solicited symptoms of reactogenicity were predefined adverse events (AEs) for which the participant was specifically questioned, and which were noted by the participant in their solicited symptom diary, including: fever (any temperature 100°F or higher), headache, myalgia (muscle pain), abdominal pain, anorexia (defined as not eating), nausea, vomiting, diarrhea, and malaise/fatigue. The severity of each solicited symptom of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening.

TEAEs:AEs that began after start of an investigational product or an already present event that worsens in intensity or frequency following intervention.An AE considered serious (SAE) if,in view of Investigator or Sponsor,it resulted in death,life-threatening AE,inpatient hospitalization/prolongation of hospitalization,persistent or significant incapacity or disability disrupting normal life functions,congenital anomaly/birth defect,or an important medical event which based upon medical judgment may have jeopardized participant and required intervention to prevent 1 of outcomes.AESIs:serious/non-serious AEs of scientific and medical concern with potential immune mediated conditions and events associated with thrombosis and thrombocytopenia.NOCI:diagnosis post-enrollment and vaccination of new chronic medical condition,including those controllable by medication.An AE was unsolicited if it did not fulfill conditions prelisted in eCRF in terms of diagnosis/onset window post-vaccination.

GMC of serum VP1 specific (G1.1) IgA was measured by Meso Scale Discovery (MSD) assay. Assay was measured in an arbitrary unit per milliliter (AU/mL).

GMC of serum VP1 specific (G2.4) IgA was measured by MSD assay. Assay is measured in AU/mL.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).

A 2, 3, 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).

A 2, 3, 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).

GMC of breastmilk VP1 specific (G1.1) IgA was measured by MSD assay. Assay is measured in Relative Light Unit per microgram (RLU)/µg of total IgA which is a normalized measure used to quantify the specific binding of IgA antibodies to norovirus VLPs (measured in RLU) relative to the total amount of IgA protein present in a breast milk.

GMC of breastmilk VP1 specific (G2.4) IgA was measured by MSD assay. Assay is measured in RLU/µg of total IgA which is a normalized measure used to quantify the specific binding of IgA antibodies to norovirus VLPs (measured in RLU) relative to the total amount of IgA protein present in a breast milk.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).

A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibody compared to pre-vaccination dosing Baseline (Day 1).

A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).

To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post initial vaccination at Day 1.

Change from baseline in VP1-specific Immunogolobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay will be evaluated at Day 8

Change from baseline in histo-blood group antigen (HBGA) blocking antibodies evaluated at Day 29

Change from baseline in VP1-specific Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay will be evaluated at Day 29

Change from baseline in VP1-specific serum IgG by Mesoscale Discovery (MSD) will be evaluated at Day 29

Comparison of rate of occurance and severity of Solicited Adverse Events observed between treatment groups

Comparison of the rate of occurrence and severity of unsolicited Adverse Events observed between treatment groups

LS Mean difference in VP1 specific IgA ASC between vaccine and placebo group

Difference in HBGA blocking antibodies (by blocking titer fifty assay \[BT50\]) between vaccine and placebo groups

Safety will be evaluated by local and systemic reactogenicity (solicited symptoms), and clinical and laboratory assessments including physical exams, vital signs, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and adverse events (AEs).

Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination