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.

SAF: All randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the treatment (vaccine) they actually received.

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.

SAF: All randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the treatment (vaccine) they actually received.

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).

Immunogenicity Analysis Set (IS): All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.

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).

IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.

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).

IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset window post-vaccination. An AESIs serious or nonserious) is one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor can be appropriate. NOCIs was defined as diagnosis post-enrollment and vaccination of a new medical condition, which is chronic in nature, including those potentially controllable by medication. Only unsolicited SAEs, AESI and NOCIs data was planned to be collected and assessed for the assessment of this OM and solicited SAEs, AESIs and NOCIs was out of the scope of assessment. Participants with unsolicited SAEs, AESIs and NOCIs throughout the trial were reported in this outcome measure.

SAF: All randomized participants who received at least 1 dose of the trial drug. Participants were analyzed according to the treatment (vaccine) they actually received.

GMC of serum VP1 specific (G1.1) IgA was measured by MSD assay. Assay is measured in AU/mL.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMC of breastmilkVP1 specific (G1.1) 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.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 60 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 60 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMC of serum VP1 specific (G1.1) IgG was measured by MSD assay. Assay is measured in AU/mL.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with available data were included in this endpoint.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

Serum BT50 (G1.1) through 6 months after trial drug dose was measured by histo-blood group antigen (HBGA) assay. Blood samples were collected at different timepoints throughout the trial.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

Serum BT50 (G2.4) through 6 months after trial drug dose was measured by HBGA assay. Blood samples were collected at different timepoints throughout the trial.

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with available data were included in this endpoint.

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).

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with available data were included in this endpoint.

GMC of nasal VP1 specific (G1.1) IgA from lactating mothers was measured by MSD assay. Assay is measured in microgram per milligram (µg/mg).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMC of nasal VP1 specific (G2.4) IgA from lactating mothers was measured by MSD assay. Assay is measured in µg/mg.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMC of saliva VP1 specific (G1.1) IgA from lactating mothers was measured by MSD assay. Assay is measured in µg/mg.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMC of saliva VP1 specific (G2.4) IgA from lactating mothers was measured by MSD assay. Assay is measured in µg/mg.

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data and at each timepoint were included.

GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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).

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

GMC of infant stool VP1 specific (G1.1) IgA was measured by Enzyme-linked immunosorbent assay (ELISA). Assay is measured in mg/gm.

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infants with evaluable data and at each timepoint were included.

GMC of infant stool VP1 specific (G2.4) IgA was measured by ELISA. Assay is measured in mg/gm.

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infants with evaluable data and at each timepoint were included.

GMFR was measured by ELISA. The fold rise was calculated per participant (infant) by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infant participants with evaluable data and at each timepoint were included.

GMFR was measured by ELISA. The fold rise was calculated per infant (participant) by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infant participants with evaluable data and at each timepoint were included.

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

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

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

IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.

Data was not collected for this outcome measure.

The outcome measure was not assessed, and so the data was not collected.