Trial Outcomes & Findings for VAXCHORA Pediatric Study to Assess Safety and Immunogenicity (NCT NCT03220737)
NCT ID: NCT03220737
Last Updated: 2023-06-28
Results Overview
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
550 participants
Primary outcome timeframe
Day 11
Results posted on
2023-06-28
Participant Flow
This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 433 and 73 completed the main study for treatment and placebo, respectively. Recruitment July 2017-July 2018.
This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 506 and 62 completed the main and sub studies, respectively. Recruitment July 2017-July 2018. The historical control subjects are not included in the protocol enrollment number for PXVX-VC-200-006. They are solely a comparator population.
Participant milestones
| Measure |
Cohort 1 (Active, 12-17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12 - 17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Historical Control: Adult Bridging Population
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
|
|---|---|---|---|---|---|---|---|
|
Main Study (Day 1 - 181)
STARTED
|
163
|
26
|
158
|
27
|
150
|
26
|
2688
|
|
Main Study (Day 1 - 181)
COMPLETED
|
157
|
24
|
146
|
24
|
130
|
25
|
2687
|
|
Main Study (Day 1 - 181)
NOT COMPLETED
|
6
|
2
|
12
|
3
|
20
|
1
|
1
|
|
Placebo Crossover (Day 181-365)
STARTED
|
13
|
0
|
11
|
0
|
7
|
0
|
0
|
|
Placebo Crossover (Day 181-365)
COMPLETED
|
13
|
0
|
11
|
0
|
5
|
0
|
0
|
|
Placebo Crossover (Day 181-365)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Long-term Follow-up (Day 365-730)
STARTED
|
73
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up (Day 365-730)
COMPLETED
|
62
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up (Day 365-730)
NOT COMPLETED
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Active, 12-17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12 - 17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Historical Control: Adult Bridging Population
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
|
|---|---|---|---|---|---|---|---|
|
Main Study (Day 1 - 181)
Withdrawal by Subject
|
4
|
1
|
4
|
1
|
4
|
0
|
0
|
|
Main Study (Day 1 - 181)
Lost to Follow-up
|
2
|
1
|
6
|
1
|
13
|
1
|
0
|
|
Main Study (Day 1 - 181)
Protocol Violation
|
0
|
0
|
1
|
1
|
3
|
0
|
1
|
|
Main Study (Day 1 - 181)
Failed Exl 8 and randomized in error
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Placebo Crossover (Day 181-365)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Long-term Follow-up (Day 365-730)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up (Day 365-730)
Lost to Follow-up
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Follow-up (Day 365-730)
Subject did not want lab drawn
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Baseline characteristics by cohort
| Measure |
Cohort 3 (Active, 2 - 5 Yrs)
n=150 Participants
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Active, 12-17 Yrs)
n=163 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12 - 17 Yrs)
n=26 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 2 (Active, 6 - 11 Yrs)
n=158 Participants
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
n=27 Participants
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
n=26 Participants
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Historical Control: Adult Bridging Population
n=2688 Participants
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118
|
Total
n=3238 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
150 Participants
n=21 Participants
|
163 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
26 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
550 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
2688 Participants
n=8 Participants
|
2688 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
3.5 years
STANDARD_DEVIATION 1.1 • n=21 Participants
|
14.4 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
8.6 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
8.7 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
3.6 years
STANDARD_DEVIATION 1.2 • n=8 Participants
|
30.0 years
STANDARD_DEVIATION 7.8 • n=8 Participants
|
9.0 years
STANDARD_DEVIATION 4.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=21 Participants
|
75 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=8 Participants
|
1482 Participants
n=8 Participants
|
1746 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=21 Participants
|
88 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
9 Participants
n=8 Participants
|
1206 Participants
n=8 Participants
|
1492 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
61 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=21 Participants
|
28 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=8 Participants
|
671 Participants
n=8 Participants
|
842 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=21 Participants
|
121 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=8 Participants
|
1855 Participants
n=8 Participants
|
2184 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=21 Participants
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
92 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=21 Participants
|
163 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
26 Participants
n=8 Participants
|
2341 Participants
n=8 Participants
|
2891 Participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
347 Participants
n=8 Participants
|
347 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 11Population: Immunogenicity Evaluable Population (IEP)
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=157 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=23 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
|
99.4 percentage of participants
Interval 95.4 to 99.9
|
0 percentage of participants
Interval 0.0 to 14.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: Immunogenicity Evaluable Population (IEP)
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=139 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=24 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
|
97.8 percentage of participants
Interval 92.5 to 99.4
|
4.2 percentage of participants
Interval 0.7 to 20.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: Immunogenicity Evaluable Population (IEP)
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=103 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=20 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
|
98.1 percentage of participants
Interval 91.5 to 99.6
|
0 percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: Immunogenicity Evaluable Population (IEP)
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=157 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=2687 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
|
99.4 percentage of participants
Interval 95.4 to 99.9
|
93.5 percentage of participants
Interval 92.3 to 94.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: Immunogenicity Evaluable Population (IEP)
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=139 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=2687 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
|
97.8 percentage of participants
Interval 92.5 to 99.4
|
93.5 percentage of participants
Interval 92.3 to 94.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: Immunogenicity Evaluable Population (IEP)
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=103 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=2687 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
|
98.1 percentage of participants
Interval 91.5 to 99.6
|
93.5 percentage of participants
Interval 92.3 to 94.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=156 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=23 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
|
100 percentage of participants
Interval 97.6 to 100.0
|
0 percentage of participants
Interval 0.0 to 14.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=156 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=23 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
|
85.6 percentage of participants
Interval 79.2 to 90.3
|
0 percentage of participants
Interval 0.0 to 14.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=156 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=23 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
|
73.5 percentage of participants
Interval 66.0 to 79.9
|
0 percentage of participants
Interval 0.0 to 15.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 365Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=70 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
|
68.6 percentage of participants
Interval 57.0 to 78.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 547Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=67 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
|
73.1 percentage of participants
Interval 61.5 to 82.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 730Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=62 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
|
64.5 percentage of participants
Interval 52.1 to 75.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=138 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=23 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
|
94.9 percentage of participants
Interval 89.9 to 97.5
|
4.3 percentage of participants
Interval 0.8 to 21.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity Evaluable Population (IEP)
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=98 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=18 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
|
93.9 percentage of participants
Interval 87.3 to 97.2
|
0 percentage of participants
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 91Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 181Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 365Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 547Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 730Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Day 8Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Day 29Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Day 181Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: The data presented is for the population that was randomized and received treatment. For Cohort 2, 2 Vaxchora subjects and 1 placebo subject were randomized, but not treated. For Cohort 3, 4 Vaxchora subjects were randomized, but not treated.
Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol.
Outcome measures
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=163 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12-17 Yrs)
n=26 Participants
Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181.
|
Cohort 2 (Active, 6 - 11 Yrs)
n=156 Participants
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
n=26 Participants
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
n=146 Participants
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
n=26 Participants
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Acceptability
|
99.4 percent of participants
|
100 percent of participants
|
91.0 percent of participants
|
96.2 percent of participants
|
79.5 percent of participants
|
73.1 percent of participants
|
Adverse Events
Cohort 1 (Active, 12-17 Yrs)
Serious events: 4 serious events
Other events: 116 other events
Deaths: 0 deaths
Cohort 1 (Placebo, 12 - 17 Yrs)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2 (Active, 6 - 11 Yrs)
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
Cohort 2 (Placebo, 6 - 11 Yrs)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 3 (Active, 2 - 5 Yrs)
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Cohort 3 (Placebo, 2 - 5 Yrs)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=165 participants at risk
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12 - 17 Yrs)
n=24 participants at risk
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 2 (Active, 6 - 11 Yrs)
n=157 participants at risk
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
n=25 participants at risk
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
n=146 participants at risk
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
n=26 participants at risk
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.61%
1/165 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.61%
1/165 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.8%
1/26 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Nervous system disorders
Convulsion
|
0.61%
1/165 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
General disorders
Local Swelling
|
0.61%
1/165 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.8%
1/26 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
Other adverse events
| Measure |
Cohort 1 (Active, 12-17 Yrs)
n=165 participants at risk
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 1 (Placebo, 12 - 17 Yrs)
n=24 participants at risk
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 2 (Active, 6 - 11 Yrs)
n=157 participants at risk
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 2 (Placebo, 6 - 11 Yrs)
n=25 participants at risk
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
Cohort 3 (Active, 2 - 5 Yrs)
n=146 participants at risk
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
|
Cohort 3 (Placebo, 2 - 5 Yrs)
n=26 participants at risk
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Placebo: Placebo control for this study is normal (0.9%) saline.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
37.6%
62/165 • Number of events 130 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
16.7%
4/24 • Number of events 10 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
27.4%
43/157 • Number of events 83 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
24.0%
6/25 • Number of events 15 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
17.1%
25/146 • Number of events 53 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
15.4%
4/26 • Number of events 7 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Nervous system disorders
Headache
|
2.4%
4/165 • Number of events 4 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Metabolism and nutrition disorders
Lack of Appetite
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
2.1%
3/146 • Number of events 3 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
General disorders
Fatigue
|
2.4%
4/165 • Number of events 4 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.4%
5/146 • Number of events 5 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.8%
1/26 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Gastrointestinal disorders
Nausea
|
22.4%
37/165 • Number of events 69 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
25.0%
6/24 • Number of events 16 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
14.0%
22/157 • Number of events 37 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
16.0%
4/25 • Number of events 11 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
6.8%
10/146 • Number of events 14 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
15.4%
4/26 • Number of events 4 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
2.1%
3/146 • Number of events 3 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
General disorders
Fever
|
1.8%
3/165 • Number of events 4 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.2%
5/157 • Number of events 6 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
2.1%
3/146 • Number of events 4 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.8%
1/26 • Number of events 3 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.61%
1/165 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.8%
1/26 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
General disorders
Vessel Puncture site pain
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Gastrointestinal disorders
Loose Stool
|
13.9%
23/165 • Number of events 30 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
20.8%
5/24 • Number of events 6 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
11.5%
18/157 • Number of events 19 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
5.5%
8/146 • Number of events 8 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
7.7%
2/26 • Number of events 2 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Gastrointestinal disorders
Rectal Tenesmus
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.2%
7/165 • Number of events 7 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.1%
6/146 • Number of events 6 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
11.5%
3/26 • Number of events 3 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Furuncle
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.2%
1/24 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
8.0%
2/25 • Number of events 2 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
2.1%
3/146 • Number of events 3 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
4.0%
1/25 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/146 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
2.1%
3/146 • Number of events 3 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/26 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/165 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/24 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/157 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.00%
0/25 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
0.68%
1/146 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
3.8%
1/26 • Number of events 1 • All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol. The data below is not for randomized subjects, but for those included in the safety population. For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo. For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
|
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