Trial Outcomes & Findings for A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants (NCT NCT07254728)
NCT ID: NCT07254728
Last Updated: 2026-04-15
Results Overview
TEAEs:AEs that began after start of an investigational product or an already present event that worsens in intensity or frequency following intervention.An AE considered serious (SAE) if,in view of Investigator or Sponsor,it resulted in death,life-threatening AE,inpatient hospitalization/prolongation of hospitalization,persistent or significant incapacity or disability disrupting normal life functions,congenital anomaly/birth defect,or an important medical event which based upon medical judgment may have jeopardized participant and required intervention to prevent 1 of outcomes.AESIs:serious/non-serious AEs of scientific and medical concern with potential immune mediated conditions and events associated with thrombosis and thrombocytopenia.NOCI:diagnosis post-enrollment and vaccination of new chronic medical condition,including those controllable by medication.An AE was unsolicited if it did not fulfill conditions prelisted in eCRF in terms of diagnosis/onset window post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
76 participants
Primary outcome timeframe
4 weeks post dose (29 days)
Results posted on
2026-04-15
Participant Flow
A total of 76 mother participants were enrolled between October 2023 and December 2024 in South Africa.
This study enrolled breastfeeding mother-infant dyads. Each dyad consisted of one lactating mother and her breastfed infant. Only mothers received the investigational product; infants did not receive any study treatment. All Participant Flow numbers (Started, Completed, Not Completed) represent mother-infant dyads.
Participant milestones
| Measure |
Arm 1 Medium Bivalent Dose
Mother participants received a medium dose (1x10\^11 IU) of bivalent vaccine VXA-G1.1-NN (G1.1) and VXA-G2.4-NS (G2.4) as oral tablets on Day 1. Infants did not receive investigational product.
|
Arm 2 High Bivalent Dose
Mother participants received a high dose (2x10\^11 IU) of bivalent vaccine VXA-G1.1-NN (G1.1) and VXA-G2.4-NS (G2.4) as oral tablets on Day 1. Infants did not receive investigational product.
|
Arm 3 Placebo
Mother participants received a matching placebo as oral tablets on Day 1. Infants did not receive placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
16
|
|
Overall Study
Mothers Started
|
30
|
30
|
16
|
|
Overall Study
Infants Started
|
30
|
30
|
16
|
|
Overall Study
COMPLETED
|
26
|
29
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
4
|
Reasons for withdrawal
| Measure |
Arm 1 Medium Bivalent Dose
Mother participants received a medium dose (1x10\^11 IU) of bivalent vaccine VXA-G1.1-NN (G1.1) and VXA-G2.4-NS (G2.4) as oral tablets on Day 1. Infants did not receive investigational product.
|
Arm 2 High Bivalent Dose
Mother participants received a high dose (2x10\^11 IU) of bivalent vaccine VXA-G1.1-NN (G1.1) and VXA-G2.4-NS (G2.4) as oral tablets on Day 1. Infants did not receive investigational product.
|
Arm 3 Placebo
Mother participants received a matching placebo as oral tablets on Day 1. Infants did not receive placebo.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
Baseline Characteristics
The baseline measure of age is reported separately for mothers and infants.
Baseline characteristics by cohort
| Measure |
Arm 1 Medium Bivalent Dose: Mothers
n=30 Participants
Participants received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1.
|
Arm 2 High Bivalent Dose: Mothers
n=30 Participants
Participants received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1.
|
Arm 3 Placebo: Mothers
n=16 Participants
Participants received a matching placebo as an oral tablet on Day 1.
|
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablet on Day 1. Infants did not receive any direct intervention.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
30 days to 11 months
|
0 Participants
n=193 Participants • The baseline measure of age is reported separately for mothers and infants.
|
0 Participants
n=193 Participants • The baseline measure of age is reported separately for mothers and infants.
|
0 Participants
n=386 Participants • The baseline measure of age is reported separately for mothers and infants.
|
30 Participants
n=13 Participants • The baseline measure of age is reported separately for mothers and infants.
|
30 Participants
n=43 Participants • The baseline measure of age is reported separately for mothers and infants.
|
16 Participants
n=1 Participants • The baseline measure of age is reported separately for mothers and infants.
|
76 Participants
n=8 Participants • The baseline measure of age is reported separately for mothers and infants.
|
|
Age, Customized
18-65 years
|
30 Participants
n=193 Participants • The baseline measure of age is reported separately for mothers and infants.
|
30 Participants
n=193 Participants • The baseline measure of age is reported separately for mothers and infants.
|
16 Participants
n=386 Participants • The baseline measure of age is reported separately for mothers and infants.
|
0 Participants
n=13 Participants • The baseline measure of age is reported separately for mothers and infants.
|
0 Participants
n=43 Participants • The baseline measure of age is reported separately for mothers and infants.
|
0 Participants
n=1 Participants • The baseline measure of age is reported separately for mothers and infants.
|
76 Participants
n=8 Participants • The baseline measure of age is reported separately for mothers and infants.
|
|
Sex: Female, Male
Female
|
30 Participants
n=193 Participants
|
30 Participants
n=193 Participants
|
16 Participants
n=386 Participants
|
15 Participants
n=13 Participants
|
19 Participants
n=43 Participants
|
6 Participants
n=1 Participants
|
116 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
15 Participants
n=13 Participants
|
11 Participants
n=43 Participants
|
10 Participants
n=1 Participants
|
36 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race
|
30 Participants
n=193 Participants • The baseline measure of race is reported separately for mothers and infants.
|
30 Participants
n=193 Participants • The baseline measure of race is reported separately for mothers and infants.
|
16 Participants
n=386 Participants • The baseline measure of race is reported separately for mothers and infants.
|
30 Participants
n=13 Participants • The baseline measure of race is reported separately for mothers and infants.
|
30 Participants
n=43 Participants • The baseline measure of race is reported separately for mothers and infants.
|
16 Participants
n=1 Participants • The baseline measure of race is reported separately for mothers and infants.
|
152 Participants
n=8 Participants • The baseline measure of race is reported separately for mothers and infants.
|
|
Race/Ethnicity, Customized
Ethnicity · Black or African American
|
29 Participants
n=193 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
27 Participants
n=193 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
15 Participants
n=386 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
29 Participants
n=13 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
27 Participants
n=43 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
15 Participants
n=1 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
142 Participants
n=8 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
|
Race/Ethnicity, Customized
Ethnicity · Others
|
1 Participants
n=193 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
3 Participants
n=193 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
1 Participants
n=386 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
1 Participants
n=13 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
3 Participants
n=43 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
1 Participants
n=1 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
10 Participants
n=8 Participants • The baseline measure of ethnicity is reported separately for mothers and infants.
|
PRIMARY outcome
Timeframe: 1 week post study dose (8 days)Population: 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.
Solicited symptoms of reactogenicity were predefined adverse events (AEs) for which the participant was specifically questioned, and which were noted by the participant in their solicited symptom diary, including: fever (any temperature 100°F or higher), headache, myalgia (muscle pain), abdominal pain, anorexia (defined as not eating), nausea, vomiting, diarrhea, and malaise/fatigue. The severity of each solicited symptom of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose
Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose
Mild
|
15 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose
Moderate
|
1 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks post dose (29 days)Population: SAF: All randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the treatment (vaccine) they actually received.
TEAEs:AEs that began after start of an investigational product or an already present event that worsens in intensity or frequency following intervention.An AE considered serious (SAE) if,in view of Investigator or Sponsor,it resulted in death,life-threatening AE,inpatient hospitalization/prolongation of hospitalization,persistent or significant incapacity or disability disrupting normal life functions,congenital anomaly/birth defect,or an important medical event which based upon medical judgment may have jeopardized participant and required intervention to prevent 1 of outcomes.AESIs:serious/non-serious AEs of scientific and medical concern with potential immune mediated conditions and events associated with thrombosis and thrombocytopenia.NOCI:diagnosis post-enrollment and vaccination of new chronic medical condition,including those controllable by medication.An AE was unsolicited if it did not fulfill conditions prelisted in eCRF in terms of diagnosis/onset window post-vaccination.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants (Mothers) With Unsolicited Treatment-emergent Adverse Events (TEAEs)
TEAEs
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants (Mothers) With Unsolicited Treatment-emergent Adverse Events (TEAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants (Mothers) With Unsolicited Treatment-emergent Adverse Events (TEAEs)
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants (Mothers) With Unsolicited Treatment-emergent Adverse Events (TEAEs)
NOCIs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8 and 29Population: Immunogenicity Analysis Set (IS): All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of serum VP1 specific (G1.1) IgA was measured by Meso Scale Discovery (MSD) assay. Assay was measured in an arbitrary unit per milliliter (AU/mL).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serum Viral Protein 1 (VP1) Specific (G1.1) Immunoglobulin A (IgA) on Days 1, 8 and 29
Day 1
|
1050560.6 AU/mL
Standard Error 1.3
|
1625693.1 AU/mL
Standard Error 1.4
|
1209786.5 AU/mL
Standard Error 1.2
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serum Viral Protein 1 (VP1) Specific (G1.1) Immunoglobulin A (IgA) on Days 1, 8 and 29
Day 8
|
3007539.8 AU/mL
Standard Error 1.4
|
4608961.1 AU/mL
Standard Error 1.3
|
1291836.6 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serum Viral Protein 1 (VP1) Specific (G1.1) Immunoglobulin A (IgA) on Days 1, 8 and 29
Day 29
|
2065978.9 AU/mL
Standard Error 1.3
|
2822260.3 AU/mL
Standard Error 1.3
|
1421687.4 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8 and 29Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of serum VP1 specific (G2.4) IgA was measured by MSD assay. Assay is measured in AU/mL.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Serum VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Day 1
|
217289.1 AU/mL
Standard Error 1.4
|
233243.3 AU/mL
Standard Error 1.4
|
211741.7 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Day 8
|
414338.2 AU/mL
Standard Error 1.3
|
667484.3 AU/mL
Standard Error 1.4
|
235517.7 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Day 29
|
350427.7 AU/mL
Standard Error 1.4
|
491546.9 AU/mL
Standard Error 1.3
|
260989.1 AU/mL
Standard Error 1.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Day 1 to Day 8 of Serum VP1 Specific (G1.1) IgA From Day 1 to Day 8
|
2.7 fold rise
Standard Error 1.2
|
3.0 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=15 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G1.1) IgA From Day 1 to Day 29
|
1.8 fold rise
Standard Error 1.2
|
1.9 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G2.4) IgA From Day 1 to Day 8
|
1.9 fold rise
Standard Error 1.2
|
2.9 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=15 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G2.4) IgA From Day 1 to Day 29
|
1.5 fold rise
Standard Error 1.1
|
2.1 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8, 29 and 180Population: IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 8: 2-fold
|
12 Participants
|
19 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 8: 3-fold
|
11 Participants
|
14 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 8: 4-fold
|
10 Participants
|
13 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 29: 2-fold
|
9 Participants
|
17 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 29: 3-fold
|
8 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 29: 4-fold
|
6 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 180: 2-fold
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 180: 3-fold
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Day 180: 4-fold
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8, 29 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 8: 2-fold
|
11 Participants
|
17 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 8: 3-fold
|
8 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 8: 4-fold
|
7 Participants
|
10 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 29: 2-fold
|
9 Participants
|
13 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 29: 3-fold
|
5 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 29: 4-fold
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 180: 2-fold
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 180: 3-fold
|
1 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Day 180: 4-fold
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8, and 29Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of breastmilk VP1 specific (G1.1) IgA was measured by MSD assay. Assay is measured in Relative Light Unit per microgram (RLU)/µg of total IgA which is a normalized measure used to quantify the specific binding of IgA antibodies to norovirus VLPs (measured in RLU) relative to the total amount of IgA protein present in a breast milk.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Breastmilk VP1 Specific (G1.1) IgA on Days 1, 8 and 29
Day 29
|
52017.9 RLU/µg of total IgA
Standard Error 1.3
|
61663.9 RLU/µg of total IgA
Standard Error 1.2
|
31963.7 RLU/µg of total IgA
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Breastmilk VP1 Specific (G1.1) IgA on Days 1, 8 and 29
Day 1
|
26300.4 RLU/µg of total IgA
Standard Error 1.2
|
26309.0 RLU/µg of total IgA
Standard Error 1.3
|
29393.5 RLU/µg of total IgA
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Breastmilk VP1 Specific (G1.1) IgA on Days 1, 8 and 29
Day 8
|
36747.1 RLU/µg of total IgA
Standard Error 1.2
|
42476.5 RLU/µg of total IgA
Standard Error 1.2
|
30427.5 RLU/µg of total IgA
Standard Error 1.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8 and 29Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of breastmilk VP1 specific (G2.4) IgA was measured by MSD assay. Assay is measured in RLU/µg of total IgA which is a normalized measure used to quantify the specific binding of IgA antibodies to norovirus VLPs (measured in RLU) relative to the total amount of IgA protein present in a breast milk.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Breastmilk VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Day 1
|
75811.2 RLU/µg of total IgA
Standard Error 1.3
|
40270.6 RLU/µg of total IgA
Standard Error 1.3
|
79636.1 RLU/µg of total IgA
Standard Error 1.5
|
—
|
—
|
—
|
|
GMC of Breastmilk VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Day 8
|
83208.0 RLU/µg of total IgA
Standard Error 1.3
|
67097.9 RLU/µg of total IgA
Standard Error 1.3
|
87120.3 RLU/µg of total IgA
Standard Error 1.5
|
—
|
—
|
—
|
|
GMC of Breastmilk VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Day 29
|
114825.2 RLU/µg of total IgA
Standard Error 1.3
|
107289.5 RLU/µg of total IgA
Standard Error 1.4
|
78850.3 RLU/µg of total IgA
Standard Error 1.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G1.1) IgA From Day 1 to Day 8
|
1.4 fold rise
Standard Error 1.1
|
1.6 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 8 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G2.4) IgA From Day 1 to Day 8
|
1.1 fold rise
Standard Error 1.1
|
1.6 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G1.1) IgA From Day 1 to Day 29
|
2.0 fold rise
Standard Error 1.2
|
2.3 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 29 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G2.4) IgA From Day 1 to Day 29
|
1.5 fold rise
Standard Error 1.2
|
2.7 fold rise
Standard Error 1.2
|
1.0 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibody compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 8: 2-fold
|
6 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 8: 3-fold
|
4 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 8: 4-fold
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 29: 2-fold
|
10 Participants
|
16 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 29: 3-fold
|
6 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 29: 4-fold
|
6 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 60: 2-fold
|
8 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 60: 4-fold
|
5 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 180: 2-fold
|
6 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 180: 3-fold
|
5 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 180: 4-fold
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Day 60: 3-fold
|
6 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 8: 2-fold
|
3 Participants
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 8: 3-fold
|
1 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 8: 4-fold
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 60: 4-fold
|
4 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 180: 2-fold
|
2 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 180: 3-fold
|
1 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 180: 4-fold
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 29: 2-fold
|
7 Participants
|
15 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 29: 3-fold
|
3 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 29: 4-fold
|
2 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 60: 2-fold
|
7 Participants
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA
Day 60: 3-fold
|
4 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: SAF: All randomized participants who received at least 1 dose of the trial drug. Participants were analyzed according to the treatment (vaccine) they actually received.
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset window post-vaccination. An AESIs serious or nonserious) is one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor can be appropriate. NOCIs was defined as diagnosis post-enrollment and vaccination of a new medical condition, which is chronic in nature, including those potentially controllable by medication. Only unsolicited SAEs, AESI and NOCIs data was planned to be collected and assessed for the assessment of this OM and solicited SAEs, AESIs and NOCIs was out of the scope of assessment. Participants with unsolicited SAEs, AESIs and NOCIs throughout the trial were reported in this outcome measure.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants With SAEs, AESIs and NOCIs Through 12 Months Post Dose
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs, AESIs and NOCIs Through 12 Months Post Dose
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs, AESIs and NOCIs Through 12 Months Post Dose
NOCIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of serum VP1 specific (G1.1) IgA was measured by MSD assay. Assay is measured in AU/mL.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Serum VP1 Specific (G1.1) IgA on Day 180
|
1276858.6 AU/mL
Standard Error 1.4
|
1344498.0 AU/mL
Standard Error 1.3
|
1187410.4 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of serum VP1 specific (G2.4) IgA was measured by MSD assay. Assay is measured in AU/mL.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Serum VP1 Specific (G2.4) IgA on Day 180
|
230142.5 AU/mL
Standard Error 1.3
|
264313.3 AU/mL
Standard Error 1.4
|
286679.6 AU/mL
Standard Error 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G1.1) IgA From Day 1 to Day 180
|
1.1 fold rise
Standard Error 1.2
|
1.0 fold rise
Standard Error 1.2
|
1.0 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G2.4) IgA From Day 1 to Day 180
|
1.0 fold rise
Standard Error 1.1
|
1.3 fold rise
Standard Error 1.1
|
1.3 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of breastmilkVP1 specific (G1.1) IgA was measured by MSD assay. Assay is measured in RLU/µg of total IgA which is a normalized measure used to quantify the specific binding of IgA antibodies to norovirus VLPs (measured in RLU) relative to the total amount of IgA protein present in a breast milk.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Breastmilk VP1 Specific (G1.1) IgA on Days 60 and 180
Day 60
|
38202.5 RLU/µg of total IgA
Standard Error 1.3
|
39691.9 RLU/µg of total IgA
Standard Error 1.2
|
22119.3 RLU/µg of total IgA
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Breastmilk VP1 Specific (G1.1) IgA on Days 60 and 180
Day 180
|
29484.2 RLU/µg of total IgA
Standard Error 1.3
|
29964.5 RLU/µg of total IgA
Standard Error 1.2
|
23367.0 RLU/µg of total IgA
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of breastmilk VP1 specific (G2.4) IgA was measured by MSD assay. Assay is measured in RLU/µg of total IgA which is a normalized measure used to quantify the specific binding of IgA antibodies to norovirus VLPs (measured in RLU) relative to the total amount of IgA protein present in a breast milk.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Breastmilk VP1 Specific (G2.4) IgA on Days 60 and 180
Day 180
|
62361.5 RLU/µg of total IgA
Standard Error 1.3
|
62051.1 RLU/µg of total IgA
Standard Error 1.4
|
59187.9 RLU/µg of total IgA
Standard Error 1.5
|
—
|
—
|
—
|
|
GMC of Breastmilk VP1 Specific (G2.4) IgA on Days 60 and 180
Day 60
|
91060.2 RLU/µg of total IgA
Standard Error 1.3
|
69170.5 RLU/µg of total IgA
Standard Error 1.3
|
58705.8 RLU/µg of total IgA
Standard Error 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 60Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 60 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G1.1) IgA From Day 1 to Day 60
|
1.5 fold rise
Standard Error 1.2
|
1.6 fold rise
Standard Error 1.2
|
0.8 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 60Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 60 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G2.4) IgA From Day 1 to Day 60
|
1.3 fold rise
Standard Error 1.2
|
1.6 fold rise
Standard Error 1.2
|
0.8 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=27 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=27 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G1.1) IgA From Day 1 to Day 180
|
1.1 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.2
|
0.8 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Day 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=27 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=27 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Breastmilk VP1 Specific (G2.4) IgA From Day 1 to Day 180
|
0.8 fold rise
Standard Error 1.2
|
1.5 fold rise
Standard Error 1.2
|
0.8 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of serum VP1 specific (G1.1) IgG was measured by MSD assay. Assay is measured in AU/mL.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Serum VP1 Specific (G1.1) Immunoglobulin G (IgG) on Days 1, 8, 29, and 180
Day 1
|
3397392.0 AU/mL
Standard Error 1.3
|
1964195.4 AU/mL
Standard Error 1.3
|
2765544.4 AU/mL
Standard Error 1.4
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G1.1) Immunoglobulin G (IgG) on Days 1, 8, 29, and 180
Day 8
|
4985139.4 AU/mL
Standard Error 1.2
|
3678526.6 AU/mL
Standard Error 1.3
|
3109431.7 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G1.1) Immunoglobulin G (IgG) on Days 1, 8, 29, and 180
Day 180
|
4590720.0 AU/mL
Standard Error 1.3
|
3044433.6 AU/mL
Standard Error 1.2
|
3753633.6 AU/mL
Standard Error 1.4
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G1.1) Immunoglobulin G (IgG) on Days 1, 8, 29, and 180
Day 29
|
6548114.2 AU/mL
Standard Error 1.3
|
6113406.5 AU/mL
Standard Error 1.2
|
3386464.1 AU/mL
Standard Error 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of serum VP1 specific (G2.4) IgG was measured by MSD assay. Assay is measured in AU/mL.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Serum VP1 Specific (G2.4) IgG on Days 1, 8, 29, and 180
Day 1
|
893913.0 AU/mL
Standard Error 1.3
|
641462.6 AU/mL
Standard Error 1.2
|
605754.7 AU/mL
Standard Error 1.4
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G2.4) IgG on Days 1, 8, 29, and 180
Day 8
|
962779.9 AU/mL
Standard Error 1.3
|
1013436.9 AU/mL
Standard Error 1.2
|
679718.6 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G2.4) IgG on Days 1, 8, 29, and 180
Day 29
|
916270.9 AU/mL
Standard Error 1.3
|
1261314.2 AU/mL
Standard Error 1.2
|
673043.6 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Serum VP1 Specific (G2.4) IgG on Days 1, 8, 29, and 180
Day 180
|
740190.3 AU/mL
Standard Error 1.3
|
808781.1 AU/mL
Standard Error 1.2
|
690756.2 AU/mL
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to Days 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G1.1) IgG From Day 1 to Days 8, 29, and 180
From Day 1 to Day 8
|
1.6 fold rise
Standard Error 1.1
|
1.8 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Serum VP1 Specific (G1.1) IgG From Day 1 to Days 8, 29, and 180
From Day 1 to Day 29
|
2.1 fold rise
Standard Error 1.2
|
2.8 fold rise
Standard Error 1.2
|
1.2 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Serum VP1 Specific (G1.1) IgG From Day 1 to Days 8, 29, and 180
From Day 1 to Day 180
|
1.5 fold rise
Standard Error 1.2
|
1.5 fold rise
Standard Error 1.2
|
1.4 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to Days 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum VP1 Specific (G2.4) IgG From Day 1 to Days 8, 29, and 180
From Day 1 to Day 29
|
1.1 fold rise
Standard Error 1.1
|
1.9 fold rise
Standard Error 1.1
|
1.0 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Serum VP1 Specific (G2.4) IgG From Day 1 to Days 8, 29, and 180
From Day 1 to Day 180
|
0.9 fold rise
Standard Error 1.2
|
1.2 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Serum VP1 Specific (G2.4) IgG From Day 1 to Days 8, 29, and 180
From Day 1 to Day 8
|
1.1 fold rise
Standard Error 1.1
|
1.6 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with available data were included in this endpoint.
A 2, 3, and 4-fold rise represents the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 8: 2-fold
|
6 Participants
|
10 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 8: 3-fold
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 8: 4-fold
|
4 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 29: 3-fold
|
6 Participants
|
14 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 29: 4-fold
|
5 Participants
|
10 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 180: 2-fold
|
8 Participants
|
11 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 29: 2-fold
|
9 Participants
|
19 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 180: 3-fold
|
5 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold, and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgG
Day 180: 4-fold
|
4 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 8: 3-fold
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 8: 4-fold
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 29: 2-fold
|
3 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 29: 3-fold
|
0 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 29: 4-fold
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 180: 2-fold
|
2 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 180: 3-fold
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 180: 4-fold
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgG
Day 8: 2-fold
|
0 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
Serum BT50 (G1.1) through 6 months after trial drug dose was measured by histo-blood group antigen (HBGA) assay. Blood samples were collected at different timepoints throughout the trial.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Blocking Titers 50 (BT50) (G1.1) on Days 1, 8, 29, and 180
Day 1
|
61.6 geometric mean titer
Standard Error 1.3
|
57.4 geometric mean titer
Standard Error 1.3
|
80.5 geometric mean titer
Standard Error 1.5
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Serum Blocking Titers 50 (BT50) (G1.1) on Days 1, 8, 29, and 180
Day 8
|
120.3 geometric mean titer
Standard Error 1.3
|
108.4 geometric mean titer
Standard Error 1.4
|
78.8 geometric mean titer
Standard Error 1.4
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Serum Blocking Titers 50 (BT50) (G1.1) on Days 1, 8, 29, and 180
Day 180
|
106.4 geometric mean titer
Standard Error 1.3
|
68.1 geometric mean titer
Standard Error 1.3
|
80.5 geometric mean titer
Standard Error 1.5
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Serum Blocking Titers 50 (BT50) (G1.1) on Days 1, 8, 29, and 180
Day 29
|
175.4 geometric mean titer
Standard Error 1.3
|
158.7 geometric mean titer
Standard Error 1.4
|
83.1 geometric mean titer
Standard Error 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
Serum BT50 (G2.4) through 6 months after trial drug dose was measured by HBGA assay. Blood samples were collected at different timepoints throughout the trial.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMT of Serum BT50 (G2.4) on Days 1, 8, 29, and 180
Day 1
|
69.1 geometric mean titer
Standard Error 1.3
|
65.2 geometric mean titer
Standard Error 1.2
|
42.0 geometric mean titer
Standard Error 1.3
|
—
|
—
|
—
|
|
GMT of Serum BT50 (G2.4) on Days 1, 8, 29, and 180
Day 8
|
62.3 geometric mean titer
Standard Error 1.2
|
68.3 geometric mean titer
Standard Error 1.2
|
33.1 geometric mean titer
Standard Error 1.2
|
—
|
—
|
—
|
|
GMT of Serum BT50 (G2.4) on Days 1, 8, 29, and 180
Day 29
|
76.0 geometric mean titer
Standard Error 1.3
|
94.4 geometric mean titer
Standard Error 1.2
|
40.6 geometric mean titer
Standard Error 1.3
|
—
|
—
|
—
|
|
GMT of Serum BT50 (G2.4) on Days 1, 8, 29, and 180
Day 180
|
49.4 geometric mean titer
Standard Error 1.2
|
56.6 geometric mean titer
Standard Error 1.2
|
40.3 geometric mean titer
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Days 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum BT50 (G1.1) From Day 1 to Days 8, 29 and 180
From Day 1 to Day 8
|
1.9 fold rise
Standard Error 1.2
|
1.9 fold rise
Standard Error 1.2
|
1.0 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
|
GMFR of Serum BT50 (G1.1) From Day 1 to Days 8, 29 and 180
From Day 1 to Day 29
|
2.7 fold rise
Standard Error 1.2
|
2.7 fold rise
Standard Error 1.2
|
1.0 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
|
GMFR of Serum BT50 (G1.1) From Day 1 to Days 8, 29 and 180
From Day 1 to Day 180
|
1.6 fold rise
Standard Error 1.2
|
1.3 fold rise
Standard Error 1.2
|
1.1 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Days 8, 29 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Serum BT50 (G2.4) From Day 1 to Days 8, 29 and 180
From Day 1 to Day 8
|
0.9 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.1
|
0.7 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Serum BT50 (G2.4) From Day 1 to Days 8, 29 and 180
From Day 1 to Day 29
|
1.1 fold rise
Standard Error 1.1
|
1.5 fold rise
Standard Error 1.1
|
0.8 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Serum BT50 (G2.4) From Day 1 to Days 8, 29 and 180
From Day 1 to Day 180
|
0.7 fold rise
Standard Error 1.1
|
0.9 fold rise
Standard Error 1.1
|
0.8 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with available data were included in this endpoint.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 8: 2-fold
|
14 Participants
|
17 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 8: 3-fold
|
8 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 8: 4-fold
|
8 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 29: 2-fold
|
21 Participants
|
23 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 29: 3-fold
|
10 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 29: 4-fold
|
10 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 180: 2-fold
|
13 Participants
|
13 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 180: 3-fold
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Achieved 2-fold, 3-fold, and 4-fold GMT Rise in Serum VP1 Specific (G1.1) IgG
Day 180: 4-fold
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 29, and 180Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with available data were included in this endpoint.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 8: 2-fold
|
4 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 8: 3-fold
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 8: 4-fold
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 29: 2-fold
|
5 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 29: 3-fold
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 29: 4-fold
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 180: 2-fold
|
2 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 180: 3-fold
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMT Rise in Serum VP1 Specific IgG (G2.4)
Day 180: 4-fold
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of nasal VP1 specific (G1.1) IgA from lactating mothers was measured by MSD assay. Assay is measured in microgram per milligram (µg/mg).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Nasal VP1 Specific (G1.1) IgA
Day 1
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.3
|
0.2 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G1.1) IgA
Day 8
|
0.3 µg/mg
Standard Error 1.2
|
0.3 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G1.1) IgA
Day 29
|
0.3 µg/mg
Standard Error 1.3
|
0.3 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G1.1) IgA
Day 60
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G1.1) IgA
Day 180
|
0.1 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of nasal VP1 specific (G2.4) IgA from lactating mothers was measured by MSD assay. Assay is measured in µg/mg.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Nasal VP1 Specific (G2.4) IgA
Day 1
|
0.1 µg/mg
Standard Error 1.3
|
0.1 µg/mg
Standard Error 1.3
|
0.1 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G2.4) IgA
Day 8
|
0.2 µg/mg
Standard Error 1.3
|
0.1 µg/mg
Standard Error 1.3
|
0.1 µg/mg
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G2.4) IgA
Day 29
|
0.2 µg/mg
Standard Error 1.3
|
0.2 µg/mg
Standard Error 1.3
|
0.1 µg/mg
Standard Error 1.4
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G2.4) IgA
Day 60
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.3
|
0.0 µg/mg
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Nasal VP1 Specific (G2.4) IgA
Day 180
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.3
|
0.1 µg/mg
Standard Error 1.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Days 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Nasal VP1 Specific (GI.I) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 8
|
1.8 fold rise
Standard Error 1.2
|
1.3 fold rise
Standard Error 1.2
|
0.7 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Nasal VP1 Specific (GI.I) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 29
|
1.7 fold rise
Standard Error 1.2
|
1.2 fold rise
Standard Error 1.2
|
0.9 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
|
GMFR of Nasal VP1 Specific (GI.I) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 60
|
0.8 fold rise
Standard Error 1.2
|
0.8 fold rise
Standard Error 1.2
|
0.5 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
|
GMFR of Nasal VP1 Specific (GI.I) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 180
|
0.7 fold rise
Standard Error 1.2
|
0.7 fold rise
Standard Error 1.2
|
0.7 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Days 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trail drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Nasal VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 8
|
1.3 fold rise
Standard Error 1.2
|
1.3 fold rise
Standard Error 1.2
|
0.7 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Nasal VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 29
|
1.7 fold rise
Standard Error 1.2
|
1.7 fold rise
Standard Error 1.2
|
0.7 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
|
GMFR of Nasal VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 60
|
0.6 fold rise
Standard Error 1.2
|
0.8 fold rise
Standard Error 1.2
|
0.4 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
|
GMFR of Nasal VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 180
|
0.5 fold rise
Standard Error 1.2
|
0.7 fold rise
Standard Error 1.2
|
0.5 fold rise
Standard Error 1.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 8: 4-fold
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 29: 2-fold
|
10 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 29: 3-fold
|
4 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 29: 4-fold
|
4 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 60: 4-fold
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 180: 2-fold
|
7 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 180: 3-fold
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 180: 4-fold
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 8: 2-fold
|
12 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 8: 3-fold
|
6 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 60: 2-fold
|
5 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G1.1)
Day 60: 3-fold
|
3 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 8: 2-fold
|
7 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 8: 3-fold
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 29: 2-fold
|
10 Participants
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 29: 3-fold
|
5 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 29: 4-fold
|
3 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 60: 2-fold
|
3 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 60: 3-fold
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 180: 2-fold
|
4 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 180: 3-fold
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 180: 4-fold
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 8: 4-fold
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Nasal VP1 Specific IgA (G2.4)
Day 60: 4-fold
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of saliva VP1 specific (G1.1) IgA from lactating mothers was measured by MSD assay. Assay is measured in µg/mg.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Saliva VP1 Specific (G1.1) IgA
Day 29
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G1.1) IgA
Day 60
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.1
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G1.1) IgA
Day 180
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.1
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G1.1) IgA
Day 1
|
0.1 µg/mg
Standard Error 1.3
|
0.2 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G1.1) IgA
Day 8
|
0.1 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
0.2 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMC of saliva VP1 specific (G2.4) IgA from lactating mothers was measured by MSD assay. Assay is measured in µg/mg.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Saliva VP1 Specific (G2.4) IgA
Day 1
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G2.4) IgA
Day 8
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.1
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G2.4) IgA
Day 29
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G2.4) IgA
Day 60
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
|
GMC of Saliva VP1 Specific (G2.4) IgA
Day 180
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
0.1 µg/mg
Standard Error 1.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Days 8, 29, 60, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data and at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Saliva VP1 Specific (G1.1) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 8
|
1.2 fold rise
Standard Error 1.1
|
1.2 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Saliva VP1 Specific (G1.1) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 29
|
1.5 fold rise
Standard Error 1.1
|
1.2 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Saliva VP1 Specific (G1.1) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 60
|
1.7 fold rise
Standard Error 1.1
|
1.2 fold rise
Standard Error 1.1
|
1.4 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
|
GMFR of Saliva VP1 Specific (G1.1) IgA From Day 1 to Days 8, 29, 60 and 180
From Day 1 to Day 180
|
1.5 fold rise
Standard Error 1.2
|
1.2 fold rise
Standard Error 1.2
|
1.2 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 1 to Days 8, 29, 60, and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
GMFR was measured by MSD assay. The fold rise was calculated per participant by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Saliva VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60, and 180
From Day 1 to Day 8
|
1.1 fold rise
Standard Error 1.1
|
1.4 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Saliva VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60, and 180
From Day 1 to Day 29
|
1.4 fold rise
Standard Error 1.1
|
1.6 fold rise
Standard Error 1.1
|
1.0 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Saliva VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60, and 180
From Day 1 to Day 60
|
1.5 fold rise
Standard Error 1.1
|
1.2 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.1
|
—
|
—
|
—
|
|
GMFR of Saliva VP1 Specific (G2.4) IgA From Day 1 to Days 8, 29, 60, and 180
From Day 1 to Day 180
|
1.1 fold rise
Standard Error 1.1
|
1.2 fold rise
Standard Error 1.1
|
1.1 fold rise
Standard Error 1.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the trial drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 29: 2-fold
|
10 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 29: 3-fold
|
5 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 29: 4-fold
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 60: 2-fold
|
12 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 60: 3-fold
|
10 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 60: 4-fold
|
6 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 180: 3-fold
|
8 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 180: 4-fold
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 8: 2-fold
|
8 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 8: 3-fold
|
5 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 8: 4-fold
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G1.1)
Day 180: 2-fold
|
11 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29, 60 and 180Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3, and 4-fold rise represented the participants with at least a 2, 3, or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 8: 2-fold
|
2 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 8: 3-fold
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 29: 4-fold
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 60: 2-fold
|
9 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 60: 3-fold
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 8: 4-fold
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 29: 2-fold
|
8 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 29: 3-fold
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 60: 4-fold
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 180: 2-fold
|
6 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 180: 3-fold
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With 2-fold, 3-fold and 4-fold GMC Rise in Saliva VP1 Specific IgA (G2.4)
Day 180: 4-fold
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 29 and 60Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infants with evaluable data and at each timepoint were included.
GMC of infant stool VP1 specific (G1.1) IgA was measured by Enzyme-linked immunosorbent assay (ELISA). Assay is measured in mg/gm.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=15 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Infant Stool VP1 Specific (G1.1) IgA
Day 1
|
0.0 milligram per gram (mg/gm)
Standard Error 1.2
|
0.0 milligram per gram (mg/gm)
Standard Error 1.4
|
0.1 milligram per gram (mg/gm)
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Infant Stool VP1 Specific (G1.1) IgA
Day 29
|
0.1 milligram per gram (mg/gm)
Standard Error 1.4
|
0.1 milligram per gram (mg/gm)
Standard Error 1.3
|
0.1 milligram per gram (mg/gm)
Standard Error 1.3
|
—
|
—
|
—
|
|
GMC of Infant Stool VP1 Specific (G1.1) IgA
Day 60
|
0.1 milligram per gram (mg/gm)
Standard Error 1.3
|
0.1 milligram per gram (mg/gm)
Standard Error 1.4
|
0.0 milligram per gram (mg/gm)
Standard Error 1.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 29 and 60Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infants with evaluable data and at each timepoint were included.
GMC of infant stool VP1 specific (G2.4) IgA was measured by ELISA. Assay is measured in mg/gm.
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=15 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMC of Infant Stool VP1 Specific (G2.4) IgA
Day 1
|
0.1 mg/gm
Standard Error 1.7
|
0.0 mg/gm
Standard Error 1.4
|
0.1 mg/gm
Standard Error 1.7
|
—
|
—
|
—
|
|
GMC of Infant Stool VP1 Specific (G2.4) IgA
Day 29
|
0.1 mg/gm
Standard Error 1.6
|
0.2 mg/gm
Standard Error 1.5
|
0.1 mg/gm
Standard Error 1.7
|
—
|
—
|
—
|
|
GMC of Infant Stool VP1 Specific (G2.4) IgA
Day 60
|
0.1 mg/gm
Standard Error 1.6
|
0.1 mg/gm
Standard Error 1.6
|
0.0 mg/gm
Standard Error 1.7
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Days 29 and 60Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infant participants with evaluable data and at each timepoint were included.
GMFR was measured by ELISA. The fold rise was calculated per participant (infant) by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=14 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Infant Stool VP1 Specific (G1.1) IgA From Day 1 to Days 29 and 60
From Day 1 to Day 29
|
3.2 fold rise
Standard Error 1.3
|
1.8 fold rise
Standard Error 1.3
|
1.4 fold rise
Standard Error 1.5
|
—
|
—
|
—
|
|
GMFR of Infant Stool VP1 Specific (G1.1) IgA From Day 1 to Days 29 and 60
From Day 1 to Day 60
|
2.8 fold rise
Standard Error 1.3
|
1.5 fold rise
Standard Error 1.3
|
1.1 fold rise
Standard Error 1.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Days 29 and 60Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only infant participants with evaluable data and at each timepoint were included.
GMFR was measured by ELISA. The fold rise was calculated per infant (participant) by dividing the least square mean value on Days 8, 29 and 180 with least square mean value at baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=28 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=29 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=14 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
GMFR of Infant Stool VP1 Specific (G2.4) IgA From Day 1 to Days 29 and 60
From Day 1 to Day 29
|
1.4 fold rise
Standard Error 1.4
|
3.3 fold rise
Standard Error 1.4
|
0.7 fold rise
Standard Error 1.6
|
—
|
—
|
—
|
|
GMFR of Infant Stool VP1 Specific (G2.4) IgA From Day 1 to Days 29 and 60
From Day 1 to Day 60
|
1.1 fold rise
Standard Error 1.3
|
1.9 fold rise
Standard Error 1.3
|
0.7 fold rise
Standard Error 1.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 29 and 60Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3 and 4-fold rise represented the participants (infants) with at least a 2, 3 or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G1.1)
Day 29: 3-fold
|
11 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G1.1)
Day 29: 4-fold
|
9 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G1.1)
Day 60: 2-fold
|
15 Participants
|
12 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G1.1)
Day 60: 3-fold
|
11 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G1.1)
Day 60: 4-fold
|
11 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G1.1)
Day 29: 2-fold
|
17 Participants
|
15 Participants
|
3 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8, 29 and 60Population: IS: All randomized participants who received at least 1 dose of the study drug and had at least 1 valid immunogenicity result after Day 1. Participants were analyzed according to the treatment (vaccine) they actually received. Only participants with evaluable data at each timepoint were included.
A 2, 3 and 4-fold rise represented the participants (infants) with at least a 2, 3 or 4-fold rise in antibodies compared to pre-vaccination dosing Baseline (Day 1).
Outcome measures
| Measure |
Arm 4 Medium Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 Participants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
n=16 Participants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 4 Medium Bivalent Dose: Infants
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
|
Arm 6 Placebo: Infants
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
|
|---|---|---|---|---|---|---|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G2.4)
Day 29: 2-fold
|
12 Participants
|
15 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G2.4)
Day 29: 3-fold
|
7 Participants
|
13 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G2.4)
Day 29: 4-fold
|
6 Participants
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G2.4)
Day 60: 2-fold
|
12 Participants
|
12 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G2.4)
Day 60: 3-fold
|
6 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Infants With 2-fold, 3-fold and 4-fold GMC Rise in Infant Stool VP1 Specific IgA (G2.4)
Day 60: 4-fold
|
5 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dose up to Day 365Population: The outcome measure was not assessed, and so the data was not collected.
Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 Medium Bivalent Dose: Mothers
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm 2 High Bivalent Dose: Mothers
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 3 Placebo: Mothers
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 4 Medium Bivalent Dose: Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 5 High Bivalent Dose: Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 6 Placebo: Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 Medium Bivalent Dose: Mothers
n=30 participants at risk
Participants received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1.
|
Arm 2 High Bivalent Dose: Mothers
n=30 participants at risk
Participants received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1.
|
Arm 3 Placebo: Mothers
n=16 participants at risk
Participants received a matching placebo as oral tablets on Day 1.
|
Arm 4 Medium Bivalent Dose: Infants
n=30 participants at risk
Infants from mother participants who received a medium dose (1\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as oral tablets on Day 1. Infants did not receive any direct intervention.
|
Arm 5 High Bivalent Dose: Infants
n=30 participants at risk
Infants from mother participants who received a high dose (2\*10\^11 IU) of bivalent vaccine G1.1 and G2.4 as an oral tablet on Day 1. Infants did not receive any direct intervention.
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Arm 6 Placebo: Infants
n=16 participants at risk
Infants from mother participants who received a matching placebo oral tablets on Day 1. Infants did not receive any direct intervention.
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|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
6/30 • From first dose up to 365 days
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.
|
26.7%
8/30 • From first dose up to 365 days
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.
|
25.0%
4/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • From first dose up to 365 days
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.
|
6.7%
2/30 • From first dose up to 365 days
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.
|
12.5%
2/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • From first dose up to 365 days
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.
|
20.0%
6/30 • From first dose up to 365 days
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.
|
6.2%
1/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
3/30 • From first dose up to 365 days
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.
|
6.7%
2/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/30 • From first dose up to 365 days
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.
|
6.7%
2/30 • From first dose up to 365 days
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.
|
6.2%
1/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
General disorders
Fever
|
6.7%
2/30 • From first dose up to 365 days
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.
|
6.7%
2/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
General disorders
Malaise/Fatigue
|
6.7%
2/30 • From first dose up to 365 days
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.
|
13.3%
4/30 • From first dose up to 365 days
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.
|
12.5%
2/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
6/30 • From first dose up to 365 days
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.
|
13.3%
4/30 • From first dose up to 365 days
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.
|
6.2%
1/16 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/30 • From first dose up to 365 days
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.
|
0.00%
0/16 • From first dose up to 365 days
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place