Trial Outcomes & Findings for A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults (NCT NCT02094586)
NCT ID: NCT02094586
Last Updated: 2023-06-28
Results Overview
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3146 participants
Primary outcome timeframe
Day 11
Results posted on
2023-06-28
Participant Flow
Following assignment to either receive PXVX0200 or placebo, subjects in the PXVX0200 arm were randomized to receive Lot A, B or C. Subjects in each of these Arms/Groups add up to the number of subjects in the PXVX0200 (Lot A, B and C) Arm/Group.
Participant milestones
| Measure |
PXVX0200 Lot A
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
927
|
933
|
935
|
351
|
|
Overall Study
COMPLETED
|
848
|
866
|
876
|
331
|
|
Overall Study
NOT COMPLETED
|
79
|
67
|
59
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Baseline characteristics by cohort
| Measure |
PXVX0200 Lot A
n=927 Participants
PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
|
PXVX0200 Lot B
n=933 Participants
PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
|
PXVX0200 Lot C
n=935 Participants
PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
|
Placebo
n=351 Participants
Placebo physiological saline
|
Total
n=3146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 45 years inclusive · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 45 years inclusive · Between 18 and 65 years
|
927 Participants
n=5 Participants
|
933 Participants
n=7 Participants
|
935 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
3146 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 45 years inclusive · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 7.54 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 7.54 • n=4 Participants
|
29.9 years
STANDARD_DEVIATION 7.76 • n=21 Participants
|
|
Sex: Female, Male
Female
|
510 Participants
n=5 Participants
|
503 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
1682 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
417 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
1464 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
222 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
806 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
649 Participants
n=5 Participants
|
626 Participants
n=7 Participants
|
655 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
2148 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
809 Participants
n=5 Participants
|
805 Participants
n=7 Participants
|
817 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
2731 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
118 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
415 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 11Population: The Immunogenicity Evaluable Population (IEP) comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity.
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Outcome measures
| Measure |
PXVX0200 Lot A
n=892 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=887 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
Placebo physiological saline
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
|
9220 Geometric Mean Titer
Interval 8219.0 to 10343.0
|
10034 Geometric Mean Titer
Interval 8942.0 to 11260.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: The Immunogenicity Evaluable Population (IEP) comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity.
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Outcome measures
| Measure |
PXVX0200 Lot A
n=887 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=909 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
Placebo physiological saline
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
|
10034 Geometric Mean Titer
Interval 8942.0 to 11260.0
|
9827 Geometric Mean Titer
Interval 8770.0 to 11012.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: The Immunogenicity Evaluable Population (IEP) comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity.
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Outcome measures
| Measure |
PXVX0200 Lot A
n=892 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=909 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
Placebo physiological saline
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
|
9220 Geometric Mean Titer
Interval 8219.0 to 10343.0
|
9827 Geometric Mean Titer
Interval 8770.0 to 11012.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 11Population: IEP - comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity
Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11
Outcome measures
| Measure |
PXVX0200 Lot A
n=892 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=887 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
n=909 Participants
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
n=334 Participants
Placebo physiological saline
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
SVA Seroconversion at Day 11
|
94 % of participants
Interval 92.0 to 96.0
|
93 % of participants
Interval 91.0 to 94.0
|
94 % of participants
Interval 92.0 to 95.0
|
4 % of participants
Interval 2.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 - 181Population: The subgroup examining long-term and specific functional immunogenicity was formed to examine specific behavior of Vaxchora based a smaller total sample size than the total study due to the complexity of the assays needed for the endpoints. As such, an analysis by lot would have rendered any examination severely underpowered and was not necessary due to the objective to examine Vaxchora vs placebo rather than the affect of lot on those endpoints.
GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
Outcome measures
| Measure |
PXVX0200 Lot A
n=26 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=6 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
Placebo physiological saline
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Anti-CT IgG GMT at Day 1
|
445 Titer
Interval 405.0 to 489.0
|
951 Titer
Interval 296.0 to 3057.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
SVA GMT at Day 1
|
91 Titer
Interval 52.0 to 162.0
|
143 Titer
Interval 12.0 to 1728.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
SVA GMT at Day 11
|
9922 Titer
Interval 4306.0 to 22865.0
|
320 Titer
Interval 6.0 to 16216.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
SVA GMT at Day 29
|
6170 Titer
Interval 3798.0 to 10025.0
|
127 Titer
Interval 10.0 to 1623.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
SVA GMT at Day 91
|
560 Titer
Interval 322.0 to 975.0
|
127 Titer
Interval 10.0 to 1623.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
SVA GMT at Day 181
|
386 Titer
Interval 211.0 to 703.0
|
53 Titer
Interval 8.0 to 348.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Anti-CT IgG GMT at Day 11
|
1780 Titer
Interval 901.0 to 3517.0
|
800 Titer
Interval 319.0 to 2008.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Anti-CT IgG GMT at Day 29
|
2007 Titer
Interval 1075.0 to 3748.0
|
848 Titer
Interval 316.0 to 2275.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Anti-CT IgG GMT at Day 91
|
1276 Titer
Interval 771.0 to 2111.0
|
599 Titer
Interval 370.0 to 972.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Anti-CT IgG GMT at Day 181
|
1116 Titer
Interval 687.0 to 1814.0
|
528 Titer
Interval 329.0 to 846.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 - 181Population: The subgroup examining long-term and specific functional immunogenicity was formed to examine specific behavior of Vaxchora based a smaller total sample size than the total study due to the complexity of the assays needed for the endpoints. As such, an analysis by lot would have rendered any examination severely underpowered and was not necessary due to the objective to examine Vaxchora vs placebo rather than the affect of lot on those endpoints.
Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.
Outcome measures
| Measure |
PXVX0200 Lot A
n=26 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=6 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
Placebo physiological saline
|
Placebo
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
SVA Seroconversion at Day 29
|
96 % of participants
Interval 80.0 to 100.0
|
0 % of participants
Interval 0.0 to 46.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
SVA Seroconversion at Day 91
|
69 % of participants
Interval 48.0 to 86.0
|
0 % of participants
Interval 0.0 to 46.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
SVA Seroconversion at Day 181
|
50 % of participants
Interval 30.0 to 70.0
|
0 % of participants
Interval 0.0 to 52.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Anti-CT IgG Seroconversion at Day 11
|
42 % of participants
Interval 23.0 to 63.0
|
0 % of participants
Interval 0.0 to 46.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Anti-CT IgG Seroconversion at Day 29
|
46 % of participants
Interval 27.0 to 67.0
|
0 % of participants
Interval 0.0 to 46.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Anti-CT IgG Seroconversion at Day 91
|
42 % of participants
Interval 23.0 to 63.0
|
0 % of participants
Interval 0.0 to 46.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Anti-CT IgG Seroconversion at Day 181
|
35 % of participants
Interval 17.0 to 56.0
|
0 % of participants
Interval 0.0 to 52.0
|
—
|
—
|
—
|
|
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
SVA Seroconversion at Day 11
|
91 % of participants
Interval 71.0 to 99.0
|
0 % of participants
Interval 0.0 to 60.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 - 29Population: Safety population - the population of randomized subjects who received study treatment and was analyzed according to the treatment actually received.
Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever \& vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29.
Outcome measures
| Measure |
PXVX0200 Lot A
n=904 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=908 Participants
A single dose PXVX0200; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
n=922 Participants
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
Placebo
n=2734 Participants
Placebo physiological saline
|
Placebo
n=350 Participants
Placebo physiological saline
Placebo
|
|---|---|---|---|---|---|
|
Adverse Events
% of Subjects with any Reactogenicity
|
52.99 % of participants
|
50.44 % of participants
|
52.28 % of participants
|
51.90 % of participants
|
43.15 % of participants
|
|
Adverse Events
% of Subjects with Diarrhea Symptoms
|
4.31 % of participants
|
3.96 % of participants
|
3.36 % of participants
|
3.88 % of participants
|
1.17 % of participants
|
|
Adverse Events
% of Subjects with Fever Symptoms
|
0.77 % of participants
|
0.77 % of participants
|
0.33 % of participants
|
0.62 % of participants
|
1.17 % of participants
|
|
Adverse Events
% of Subjects with Nausea/Vomiting
|
18.03 % of participants
|
18.94 % of participants
|
18.00 % of participants
|
18.32 % of participants
|
15.16 % of participants
|
|
Adverse Events
% of Subjects with Headache
|
30.09 % of participants
|
26.43 % of participants
|
30.26 % of participants
|
28.93 % of participants
|
23.62 % of participants
|
Adverse Events
PXVX0200 Lot A
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
PXVX0200 Lot B
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
PXVX0200 Lot C
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
All PXVX0200 Lots
Serious events: 20 serious events
Other events: 290 other events
Deaths: 1 deaths
Placebo
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PXVX0200 Lot A
n=926 participants at risk
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=928 participants at risk
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
n=935 participants at risk
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
All PXVX0200 Lots
n=2789 participants at risk
All PXVX0200 Lots
|
Placebo
n=350 participants at risk
Placebo physiological saline
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.29%
1/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.22%
2/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.07%
2/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.29%
1/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.29%
1/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.29%
1/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Nervous system disorders
Convulsion
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Psychiatric disorders
Completed Suicide
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Psychiatric disorders
Depression
|
0.11%
1/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.07%
2/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/926 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/928 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.11%
1/935 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.04%
1/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.00%
0/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
Other adverse events
| Measure |
PXVX0200 Lot A
n=926 participants at risk
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot B
n=928 participants at risk
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
PXVX0200 Lot C
n=935 participants at risk
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10\^9 CFU in a liquid suspension
|
All PXVX0200 Lots
n=2789 participants at risk
All PXVX0200 Lots
|
Placebo
n=350 participants at risk
Placebo physiological saline
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
2.7%
75/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
3.1%
11/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
General disorders
Fatigue
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
2.1%
59/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
2.3%
8/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
2.0%
57/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
1.4%
5/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
1.4%
38/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.86%
3/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Gastrointestinal disorders
Flatulence
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
1.1%
32/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
1.1%
4/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
|
Gastrointestinal disorders
Abdominal Pain
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
—
0/0 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
1.0%
29/2789 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
0.57%
2/350 • Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
|
Additional Information
David Cassie, Scientist, Clinical Research
Emergent BioSolutions Canada Inc.
Phone: 204-275-4589
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60