Solicited adverse events (AEs) are predefined signs and symptoms of reactogenicity for which the participants were specifically questioned, and which were noted by the participant in their Solicited Symptom Diary for 7 days after drug administration, including:

• fever (any temperature 100.4°F or higher)
• headache
• myalgia (muscle pain)
• abdominal pain
• anorexia (defined as not eating)
• nausea
• vomiting
• diarrhoea
• malaise/fatigue.

The severity of each solicited symptoms of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening. Participants with multiple Solicited AEs were only counted once in summarizing overall percentages of Solicited AEs, the highest severity of which was used.

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

Treatment emergent AEs (TEAEs) are defined as AEs that occurred following the first administration of study medication. An unsolicited AE is an observed AE that did not fulfill the conditions prelisted in terms of diagnosis and/or onset window post-vaccination.

The severity of each AE was graded by the participant as mild, moderate or severe/ life-threatening.

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

Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and humoral immune (HI) function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.

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

Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.

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

Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.

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

Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.

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

Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.

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

Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.

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

Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.

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

Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.

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

Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.

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

Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1).

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

Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.

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

Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.

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