Trial Outcomes & Findings for A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (NCT NCT05626803)
NCT ID: NCT05626803
Last Updated: 2025-04-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Up to Day 8
Results posted on
2025-04-15
Participant Flow
A total of 135 participants were enrolled between January 2023 and October 2023 in the Unites States.
Participant milestones
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
Participants received matching placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
10
|
25
|
|
Overall Study
COMPLETED
|
50
|
49
|
10
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
Participants received matching placebo.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 8Population: SAF: All randomized participants received at least 1 dose of the study drug. Participants were analyzed according to the treatment (vaccine) they actually received.
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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Mild
|
20 Participants
|
20 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Moderate
|
3 Participants
|
9 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
Mild
|
5 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Unsolicited AEs
Moderate
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited AEs
Severe/ Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Serum - Anti-Vaccine Protein 1 (VP1) GI.1 Immunoglobulin A (IgA) Levels by Meso Scale Discovery (MSD) Assay
Day 1
|
461471.1 AU/mL
Interval 294526.0 to 723045.2
|
519763.7 AU/mL
Interval 318805.2 to 847396.3
|
149810.3 AU/mL
Interval 47236.2 to 475125.2
|
533470.9 AU/mL
Interval 255503.2 to 1113846.0
|
|
Serum - Anti-Vaccine Protein 1 (VP1) GI.1 Immunoglobulin A (IgA) Levels by Meso Scale Discovery (MSD) Assay
Day 29
|
1456125.4 AU/mL
Interval 956707.8 to 2216247.4
|
1913341.7 AU/mL
Interval 1257483.5 to 2911272.0
|
657853.4 AU/mL
Interval 248820.3 to 1739291.7
|
545855.7 AU/mL
Interval 259791.3 to 1146914.6
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Fold Rise in Serum - Anti-VP1 GI.1 IgA Levels by MSD Assay
|
3.16 Fold Rise
Interval 2.35 to 4.24
|
3.68 Fold Rise
Interval 2.8 to 4.84
|
4.39 Fold Rise
Interval 2.22 to 8.68
|
1.02 Fold Rise
Interval 0.95 to 1.1
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Serum - Anti-VP1 GII.4 IgGA Levels by MSD Assay
Day 1
|
161875.6 AU/mL
Interval 94846.4 to 276275.2
|
259428.2 AU/mL
Interval 161931.1 to 415627.3
|
210263.7 AU/mL
Interval 59975.1 to 737152.9
|
154353.5 AU/mL
Interval 67958.7 to 350580.5
|
|
Serum - Anti-VP1 GII.4 IgGA Levels by MSD Assay
Day 29
|
660009.0 AU/mL
Interval 417023.3 to 1044574.4
|
1132279.0 AU/mL
Interval 789453.9 to 1623977.9
|
1213636.4 AU/mL
Interval 616105.1 to 2390685.1
|
185430.7 AU/mL
Interval 81633.1 to 421208.4
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Fold Rise in Serum - Anti-VP1 GII.4 IgA Levels by MSD Assay
|
4.07 Fold Rise
Interval 2.78 to 5.98
|
4.36 Fold Rise
Interval 3.25 to 5.85
|
5.78 Fold Rise
Interval 1.82 to 18.33
|
1.20 Fold Rise
Interval 0.82 to 1.75
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Serum - Anti-VP1 GI.1 Immunoglobulin G (IgG) Levels by MSD Assay
Day 1
|
581088.4 AU/mL
Interval 375777.2 to 898574.5
|
413505.3 AU/mL
Interval 271032.1 to 630872.5
|
227560.5 AU/mL
Interval 77474.5 to 668397.0
|
585351.0 AU/mL
Interval 324390.2 to 1056245.7
|
|
Serum - Anti-VP1 GI.1 Immunoglobulin G (IgG) Levels by MSD Assay
Day 29
|
1612583.2 AU/mL
Interval 1089047.2 to 2387797.7
|
1203384.0 AU/mL
Interval 810726.2 to 1786216.9
|
670462.8 AU/mL
Interval 225913.2 to 1989792.5
|
575375.0 AU/mL
Interval 315269.9 to 1050073.1
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Fold Rise in Serum - Anti-VP1 GI.1 IgG Levels by MSD Assay
|
2.78 Fold Rise
Interval 2.07 to 3.72
|
2.91 Fold Rise
Interval 2.29 to 3.71
|
2.95 Fold Rise
Interval 2.25 to 3.86
|
0.98 Fold Rise
Interval 0.93 to 1.04
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Day 1
|
271643.8 AU/mL
Interval 187461.8 to 393628.7
|
242957.4 AU/mL
Interval 166040.8 to 355504.8
|
213650.0 AU/mL
Interval 90624.7 to 503685.4
|
252459.1 AU/mL
Interval 145831.9 to 437048.4
|
|
Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Day 29
|
800970.2 AU/mL
Interval 583219.1 to 1100021.2
|
837784.5 AU/mL
Interval 594378.9 to 1180867.6
|
841249.4 AU/mL
Interval 402948.8 to 1756303.8
|
247733.5 AU/mL
Interval 142572.8 to 430459.9
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Fold Rise in Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
|
2.95 Fold Rise
Interval 2.15 to 4.04
|
3.45 Fold Rise
Interval 2.7 to 4.4
|
3.94 Fold Rise
Interval 2.01 to 7.7
|
0.98 Fold Rise
Interval 0.89 to 1.09
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Serum - Anti-VP1 GI.1 Blocking Antibodies (BT50) Titers by MSD Assay
Day 1
|
41.9 Titer
Interval 29.5 to 59.6
|
41.3 Titer
Interval 28.0 to 60.9
|
20.3 Titer
Interval 10.5 to 39.4
|
40.6 Titer
Interval 21.7 to 76.0
|
|
Serum - Anti-VP1 GI.1 Blocking Antibodies (BT50) Titers by MSD Assay
Day 29
|
71.2 Titer
Interval 49.6 to 102.3
|
75.4 Titer
Interval 50.5 to 112.5
|
33.0 Titer
Interval 13.3 to 82.1
|
42.3 Titer
Interval 23.5 to 76.4
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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).
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Fold Rise in Serum - Anti-VP1 GI.1 BT50 Titers by MSD Assay
|
1.71 Fold Rise
Interval 1.29 to 2.27
|
1.82 Fold Rise
Interval 1.5 to 2.22
|
1.62 Fold Rise
Interval 1.01 to 2.6
|
1.04 Fold Rise
Interval 0.89 to 1.23
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
Day 1
|
42.0 Titer
Interval 29.4 to 60.0
|
51.8 Titer
Interval 36.6 to 73.4
|
48.3 Titer
Interval 23.4 to 99.7
|
38.4 Titer
Interval 23.4 to 63.2
|
|
Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
Day 29
|
108.7 Titer
Interval 80.3 to 147.0
|
138.5 Titer
Interval 100.9 to 190.0
|
123.1 Titer
Interval 64.1 to 236.5
|
40.6 Titer
Interval 25.1 to 65.6
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: 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.
Outcome measures
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=49 Participants
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 Participants
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 Participants
Participants received matching placebo.
|
|---|---|---|---|---|
|
Fold Rise in Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
|
2.58 Fold Rise
Interval 1.96 to 3.4
|
2.67 Fold Rise
Interval 1.95 to 3.65
|
2.55 Fold Rise
Interval 1.33 to 4.89
|
1.06 Fold Rise
Interval 0.92 to 1.22
|
Adverse Events
Bivalent GI.1/GII.4 Vaccine Medium Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Bivalent GI.1/GII.4 Vaccine High Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sentinels Open Label High Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bivalent GI.1/GII.4 Vaccine Medium Dose
n=50 participants at risk
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) medium dose vaccine 5×10\^10 tablets. Total dose was 1×10\^11 IU/dose.
|
Bivalent GI.1/GII.4 Vaccine High Dose
n=50 participants at risk
Participants received a single dose of bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Sentinels Open Label High Dose
n=10 participants at risk
Participants received a single dose of open label bivalent GI.1/GII.4 (VXA-G1.1-NN plus VXA-GII.4-NS) high dose vaccine 1×10\^11 tablets. Total dose was 2×10\^11 IU/dose.
|
Placebo
n=25 participants at risk
Participants received matching placebo.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
10.0%
1/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
1/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
10.0%
1/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Infections and infestations
Viral infection
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
1/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
1/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
10.0%
1/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
1/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
2/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
General disorders
Chills
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
General disorders
Fatigue
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
1/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
General disorders
Malaise
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
4.0%
1/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
2.0%
1/50 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/10 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
0.00%
0/25 • For TEAEs: Up to Day 29 For SAEs and all-cause mortality: Up to Day 180
For AEs and SAEs, 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. For all-cause mortality, Full Analysis Set (FAS): All participants who were randomized. The analyses using FAS were based upon the randomization arm allocated. participants were analyzed according to the treatment (vaccine) planned.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place