Trial Outcomes & Findings for Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh (NCT NCT02531802)

Results Overview

Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

475 participants

Primary outcome timeframe

7 days after each vaccination (Day 7 and Day 21)

Results posted on

2018-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Adult: ETVAX (Full) Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Received Vaccination 1 STARTED	15	15	15	15	15	3	15	15	15	52	15	15	15	15	40	30	30	30	30	30	50
Received Vaccination 1 COMPLETED	15	15	15	15	15	3	15	15	15	52	15	15	15	15	40	30	30	30	30	30	50
Received Vaccination 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Received Vaccination 2 STARTED	15	15	15	15	15	3	15	15	15	52	15	15	15	15	40	30	30	30	30	30	50
Received Vaccination 2 COMPLETED	15	15	14	15	15	0	15	15	15	49	13	15	13	13	39	30	30	26	27	29	49
Received Vaccination 2 NOT COMPLETED	0	0	1	0	0	3	0	0	0	3	2	0	2	2	1	0	0	4	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Adult: Placebo Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (Full) 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Received Vaccination 2 Medication interfering with study taken	1	0	1	1	1	0	0	0	1	0	0
Received Vaccination 2 Physician Decision	0	1	2	0	0	1	0	1	0	0	0
Received Vaccination 2 Adverse Event	0	2	0	0	0	0	0	2	1	0	1
Received Vaccination 2 Withdrawal by Subject	0	0	0	1	1	1	1	1	1	1	0

Baseline Characteristics

Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult: Placebo n=15 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=52 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=3 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=40 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo n=50 Participants 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=30 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	Total n=475 Participants Total of all reporting groups
Age, Continuous	31.5 years STANDARD_DEVIATION 5.58 • n=5 Participants	30.1 years STANDARD_DEVIATION 6.96 • n=7 Participants	29.4 years STANDARD_DEVIATION 6.96 • n=5 Participants	3.7 years STANDARD_DEVIATION 0.77 • n=4 Participants	4.1 years STANDARD_DEVIATION 0.62 • n=21 Participants	3.4 years STANDARD_DEVIATION 0.68 • n=8 Participants	4.2 years STANDARD_DEVIATION 0.59 • n=8 Participants	3.4 years STANDARD_DEVIATION 0.86 • n=24 Participants	3.6 years STANDARD_DEVIATION 0.91 • n=42 Participants	3.4 years STANDARD_DEVIATION 0.73 • n=42 Participants	1.4 years STANDARD_DEVIATION 0.27 • n=42 Participants	1.3 years STANDARD_DEVIATION 0.21 • n=42 Participants	1.5 years STANDARD_DEVIATION 0.30 • n=36 Participants	1.6 years STANDARD_DEVIATION 0.28 • n=36 Participants	1.4 years STANDARD_DEVIATION 0.27 • n=24 Participants	0.7 years STANDARD_DEVIATION 0.13 • n=135 Participants	0.7 years STANDARD_DEVIATION 0.15 • n=136 Participants	0.7 years STANDARD_DEVIATION 0.14 • n=44 Participants	0.7 years STANDARD_DEVIATION 0.11 • n=667 Participants	0.7 years STANDARD_DEVIATION 0.15 • n=15 Participants	0.6 years STANDARD_DEVIATION 0.10 • n=40 Participants	4.4 years STANDARD_DEVIATION 8.7 • n=40 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=8 Participants	2 Participants n=8 Participants	6 Participants n=24 Participants	7 Participants n=42 Participants	9 Participants n=42 Participants	20 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=36 Participants	7 Participants n=36 Participants	10 Participants n=24 Participants	23 Participants n=135 Participants	14 Participants n=136 Participants	19 Participants n=44 Participants	16 Participants n=667 Participants	18 Participants n=15 Participants	16 Participants n=40 Participants	249 Participants n=40 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	26 Participants n=4 Participants	5 Participants n=21 Participants	9 Participants n=8 Participants	1 Participants n=8 Participants	9 Participants n=24 Participants	8 Participants n=42 Participants	6 Participants n=42 Participants	20 Participants n=42 Participants	9 Participants n=42 Participants	10 Participants n=36 Participants	8 Participants n=36 Participants	5 Participants n=24 Participants	27 Participants n=135 Participants	16 Participants n=136 Participants	11 Participants n=44 Participants	14 Participants n=667 Participants	12 Participants n=15 Participants	14 Participants n=40 Participants	226 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	52 Participants n=4 Participants	15 Participants n=21 Participants	15 Participants n=8 Participants	3 Participants n=8 Participants	15 Participants n=24 Participants	15 Participants n=42 Participants	15 Participants n=42 Participants	40 Participants n=42 Participants	15 Participants n=42 Participants	15 Participants n=36 Participants	15 Participants n=36 Participants	15 Participants n=24 Participants	50 Participants n=135 Participants	30 Participants n=136 Participants	30 Participants n=44 Participants	30 Participants n=667 Participants	30 Participants n=15 Participants	30 Participants n=40 Participants	475 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Height	154.69 centimeters STANDARD_DEVIATION 8.01 • n=5 Participants	155.29 centimeters STANDARD_DEVIATION 9.38 • n=7 Participants	154.26 centimeters STANDARD_DEVIATION 10.16 • n=5 Participants	97.02 centimeters STANDARD_DEVIATION 6.84 • n=4 Participants	97.73 centimeters STANDARD_DEVIATION 5.33 • n=21 Participants	93.73 centimeters STANDARD_DEVIATION 7.08 • n=8 Participants	96.67 centimeters STANDARD_DEVIATION 2.52 • n=8 Participants	90.33 centimeters STANDARD_DEVIATION 6.11 • n=24 Participants	94.13 centimeters STANDARD_DEVIATION 7.27 • n=42 Participants	92.2 centimeters STANDARD_DEVIATION 6.59 • n=42 Participants	77.83 centimeters STANDARD_DEVIATION 4.60 • n=42 Participants	76.27 centimeters STANDARD_DEVIATION 2.99 • n=42 Participants	79.33 centimeters STANDARD_DEVIATION 4.27 • n=36 Participants	79.2 centimeters STANDARD_DEVIATION 4.69 • n=36 Participants	76.6 centimeters STANDARD_DEVIATION 2.59 • n=24 Participants	67.64 centimeters STANDARD_DEVIATION 3.44 • n=135 Participants	68.83 centimeters STANDARD_DEVIATION 3.04 • n=136 Participants	67.77 centimeters STANDARD_DEVIATION 3.45 • n=44 Participants	68.83 centimeters STANDARD_DEVIATION 3.04 • n=667 Participants	66.73 centimeters STANDARD_DEVIATION 3.14 • n=15 Participants	67.57 centimeters STANDARD_DEVIATION 2.58 • n=40 Participants	85.6 centimeters STANDARD_DEVIATION 25.6 • n=40 Participants
Weight	56.65 kilograms STANDARD_DEVIATION 9.867 • n=5 Participants	56.86 kilograms STANDARD_DEVIATION 11.776 • n=7 Participants	55.25 kilograms STANDARD_DEVIATION 11.441 • n=5 Participants	13.71 kilograms STANDARD_DEVIATION 2.043 • n=4 Participants	13.59 kilograms STANDARD_DEVIATION 1.488 • n=21 Participants	13.61 kilograms STANDARD_DEVIATION 1.914 • n=8 Participants	12.43 kilograms STANDARD_DEVIATION 0.513 • n=8 Participants	12.1 kilograms STANDARD_DEVIATION 1.465 • n=24 Participants	13.35 kilograms STANDARD_DEVIATION 1.957 • n=42 Participants	12.61 kilograms STANDARD_DEVIATION 1.936 • n=42 Participants	9.47 kilograms STANDARD_DEVIATION 1.226 • n=42 Participants	9.23 kilograms STANDARD_DEVIATION 0.959 • n=42 Participants	9.64 kilograms STANDARD_DEVIATION 0.946 • n=36 Participants	9.5 kilograms STANDARD_DEVIATION 1.271 • n=36 Participants	9.24 kilograms STANDARD_DEVIATION 0.998 • n=24 Participants	7.66 kilograms STANDARD_DEVIATION 0.958 • n=135 Participants	7.84 kilograms STANDARD_DEVIATION 1.006 • n=136 Participants	7.37 kilograms STANDARD_DEVIATION 0.728 • n=44 Participants	7.85 kilograms STANDARD_DEVIATION 1.226 • n=667 Participants	7.41 kilograms STANDARD_DEVIATION 0.876 • n=15 Participants	7.76 kilograms STANDARD_DEVIATION 0.598 • n=40 Participants	14.2 kilograms STANDARD_DEVIATION 14.3 • n=40 Participants

PRIMARY outcome

Timeframe: 7 days after each vaccination (Day 7 and Day 21)

Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=15 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=52 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=40 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=15 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=3 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=30 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo n=50 Participants 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Abdominal pain/stomach ache · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Abdominal pain/stomach ache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Diarrhea · None	14 Participants	15 Participants	52 Participants	14 Participants	14 Participants	15 Participants	40 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	30 Participants	28 Participants	29 Participants	29 Participants	50 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Diarrhea · Mild	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Diarrhea · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Acute systemic allergic reaction · None	15 Participants	15 Participants	52 Participants	15 Participants	15 Participants	15 Participants	40 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	30 Participants	30 Participants	30 Participants	30 Participants	50 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Acute systemic allergic reaction · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Acute systemic allergic reaction · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Nausea · None	15 Participants	15 Participants	52 Participants	15 Participants	15 Participants	15 Participants	40 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	30 Participants	30 Participants	30 Participants	30 Participants	50 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Nausea · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Nausea · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Any symptom · None	7 Participants	12 Participants	50 Participants	12 Participants	13 Participants	9 Participants	40 Participants	15 Participants	14 Participants	15 Participants	13 Participants	14 Participants	1 Participants	11 Participants	14 Participants	26 Participants	23 Participants	17 Participants	22 Participants	22 Participants	46 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Any symptom · Mild	8 Participants	3 Participants	2 Participants	2 Participants	2 Participants	5 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants	0 Participants	4 Participants	7 Participants	10 Participants	7 Participants	8 Participants	4 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Any symptom · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Elevated oral temperature · None	14 Participants	15 Participants	50 Participants	14 Participants	15 Participants	12 Participants	39 Participants	15 Participants	14 Participants	15 Participants	15 Participants	14 Participants	3 Participants	12 Participants	15 Participants	28 Participants	28 Participants	28 Participants	28 Participants	27 Participants	48 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Elevated oral temperature · Mild	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants	1 Participants	2 Participants	3 Participants	2 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Elevated oral temperature · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Vomiting · None	7 Participants	12 Participants	52 Participants	13 Participants	14 Participants	13 Participants	40 Participants	15 Participants	15 Participants	15 Participants	13 Participants	15 Participants	1 Participants	13 Participants	14 Participants	28 Participants	25 Participants	20 Participants	23 Participants	25 Participants	48 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Vomiting · Mild	8 Participants	3 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	5 Participants	8 Participants	6 Participants	5 Participants	2 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Vomiting · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Loose stools · None	15 Participants	15 Participants	52 Participants	15 Participants	15 Participants	12 Participants	40 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	29 Participants	29 Participants	30 Participants	30 Participants	50 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Loose stools · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Loose stools · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity Abdominal pain/stomach ache · None	15 Participants	15 Participants	52 Participants	15 Participants	15 Participants	15 Participants	40 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	30 Participants	30 Participants	30 Participants	30 Participants	50 Participants

PRIMARY outcome

Timeframe: 6 months ± 14 days after the first dose

Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=15 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=52 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=40 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=15 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=3 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=30 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo n=50 Participants 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Alanine aminotransferase increased · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Alanine aminotransferase increased · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Alanine aminotransferase increased · No AE related to vaccine	15 Participants	15 Participants	52 Participants	15 Participants	15 Participants	15 Participants	39 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	30 Participants	30 Participants	30 Participants	30 Participants	49 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Alanine aminotransferase increased · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Leukocytosis · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Leukocytosis · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Leukocytosis · Severe	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine Leukocytosis · No AE related to vaccine	15 Participants	15 Participants	52 Participants	14 Participants	15 Participants	14 Participants	38 Participants	15 Participants	14 Participants	15 Participants	15 Participants	15 Participants	3 Participants	15 Participants	15 Participants	30 Participants	30 Participants	30 Participants	30 Participants	30 Participants	50 Participants

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=24 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CFA/I · Yes	3 Participants	3 Participants	11 Participants	11 Participants	9 Participants	9 Participants	15 Participants	15 Participants	15 Participants	0 Participants	15 Participants	14 Participants	15 Participants	14 Participants	13 Participants	9 Participants	12 Participants	10 Participants	7 Participants	7 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CFA/I · No	36 Participants	46 Participants	2 Participants	4 Participants	4 Participants	4 Participants	15 Participants	0 Participants	0 Participants	14 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	21 Participants	12 Participants	16 Participants	22 Participants	42 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS3 · Yes	6 Participants	7 Participants	11 Participants	13 Participants	12 Participants	7 Participants	15 Participants	15 Participants	15 Participants	4 Participants	15 Participants	14 Participants	15 Participants	13 Participants	15 Participants	13 Participants	13 Participants	13 Participants	11 Participants	8 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS3 · No	33 Participants	42 Participants	2 Participants	2 Participants	1 Participants	6 Participants	15 Participants	0 Participants	0 Participants	10 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	17 Participants	11 Participants	13 Participants	18 Participants	41 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS5 · Yes	3 Participants	2 Participants	8 Participants	7 Participants	6 Participants	8 Participants	11 Participants	15 Participants	15 Participants	0 Participants	14 Participants	13 Participants	12 Participants	12 Participants	11 Participants	6 Participants	5 Participants	5 Participants	3 Participants	7 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS5 · No	36 Participants	47 Participants	5 Participants	8 Participants	7 Participants	5 Participants	19 Participants	0 Participants	0 Participants	14 Participants	1 Participants	2 Participants	3 Participants	3 Participants	4 Participants	24 Participants	19 Participants	21 Participants	26 Participants	42 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS6 · Yes	5 Participants	1 Participants	6 Participants	5 Participants	9 Participants	5 Participants	3 Participants	15 Participants	15 Participants	1 Participants	12 Participants	12 Participants	14 Participants	12 Participants	10 Participants	5 Participants	5 Participants	0 Participants	0 Participants	2 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS6 · No	34 Participants	48 Participants	6 Participants	10 Participants	4 Participants	8 Participants	27 Participants	0 Participants	0 Participants	13 Participants	3 Participants	3 Participants	1 Participants	3 Participants	5 Participants	25 Participants	19 Participants	26 Participants	29 Participants	47 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen LTB · Yes	6 Participants	4 Participants	13 Participants	15 Participants	13 Participants	11 Participants	19 Participants	15 Participants	15 Participants	0 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	24 Participants	20 Participants	18 Participants	21 Participants	15 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen LTB · No	33 Participants	45 Participants	0 Participants	0 Participants	0 Participants	2 Participants	11 Participants	0 Participants	0 Participants	14 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	4 Participants	8 Participants	8 Participants	34 Participants	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=24 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CFA/I · Yes	3 Participants	1 Participants	10 Participants	10 Participants	7 Participants	7 Participants	10 Participants	15 Participants	15 Participants	0 Participants	15 Participants	12 Participants	14 Participants	14 Participants	12 Participants	7 Participants	9 Participants	9 Participants	4 Participants	4 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CFA/I · No	36 Participants	48 Participants	3 Participants	5 Participants	6 Participants	6 Participants	20 Participants	0 Participants	0 Participants	14 Participants	0 Participants	3 Participants	1 Participants	1 Participants	3 Participants	23 Participants	15 Participants	17 Participants	25 Participants	45 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS3 · Yes	3 Participants	6 Participants	7 Participants	11 Participants	11 Participants	6 Participants	10 Participants	15 Participants	15 Participants	3 Participants	15 Participants	13 Participants	15 Participants	11 Participants	15 Participants	7 Participants	7 Participants	7 Participants	8 Participants	6 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS3 · No	36 Participants	43 Participants	6 Participants	4 Participants	2 Participants	7 Participants	20 Participants	0 Participants	0 Participants	11 Participants	0 Participants	2 Participants	0 Participants	4 Participants	0 Participants	23 Participants	17 Participants	19 Participants	21 Participants	43 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS5 · Yes	1 Participants	1 Participants	6 Participants	7 Participants	5 Participants	8 Participants	8 Participants	15 Participants	15 Participants	0 Participants	14 Participants	13 Participants	12 Participants	11 Participants	9 Participants	2 Participants	3 Participants	3 Participants	2 Participants	3 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS5 · No	38 Participants	48 Participants	7 Participants	8 Participants	8 Participants	5 Participants	22 Participants	0 Participants	0 Participants	14 Participants	1 Participants	2 Participants	3 Participants	4 Participants	6 Participants	28 Participants	21 Participants	23 Participants	27 Participants	46 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS6 · Yes	1 Participants	0 Participants	3 Participants	4 Participants	8 Participants	3 Participants	2 Participants	15 Participants	15 Participants	1 Participants	11 Participants	7 Participants	12 Participants	8 Participants	9 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS6 · No	38 Participants	49 Participants	9 Participants	11 Participants	5 Participants	10 Participants	28 Participants	0 Participants	0 Participants	13 Participants	4 Participants	8 Participants	3 Participants	7 Participants	6 Participants	29 Participants	24 Participants	26 Participants	28 Participants	49 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen LTB · Yes	3 Participants	2 Participants	11 Participants	15 Participants	13 Participants	11 Participants	15 Participants	15 Participants	15 Participants	0 Participants	15 Participants	15 Participants	15 Participants	15 Participants	14 Participants	20 Participants	18 Participants	15 Participants	19 Participants	8 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen LTB · No	36 Participants	47 Participants	2 Participants	0 Participants	0 Participants	2 Participants	15 Participants	0 Participants	0 Participants	14 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	10 Participants	6 Participants	11 Participants	10 Participants	41 Participants	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=24 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CFA/I	155 titer Interval 108.0 to 222.0	149 titer Interval 135.0 to 165.0	1490 titer Interval 594.0 to 3741.0	2937 titer Interval 783.0 to 11013.0	577 titer Interval 175.0 to 1900.0	862 titer Interval 262.0 to 2842.0	318 titer Interval 156.0 to 649.0	9991 titer Interval 5436.0 to 18363.0	6732 titer Interval 4023.0 to 11264.0	115 titer Interval 96.6 to 137.0	7298 titer Interval 3881.0 to 13724.0	2913 titer Interval 1051.0 to 8072.0	7819 titer Interval 3265.0 to 18726.0	2239 titer Interval 980.0 to 5114.0	3164 titer Interval 1014.0 to 9878.0	228 titer Interval 108.0 to 480.0	328 titer Interval 143.0 to 755.0	202 titer Interval 94.7 to 429.0	123 titer Interval 79.3 to 191.0	104 titer Interval 78.8 to 138.0	—
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS3	134 titer Interval 106.0 to 169.0	190 titer Interval 154.0 to 234.0	600 titer Interval 240.0 to 1502.0	1322 titer Interval 601.0 to 2906.0	1346 titer Interval 470.0 to 3853.0	700 titer Interval 208.0 to 2360.0	355 titer Interval 198.0 to 639.0	11354 titer Interval 6183.0 to 20848.0	7658 titer Interval 4208.0 to 13937.0	221 titer Interval 115.0 to 424.0	9277 titer Interval 4408.0 to 19525.0	2283 titer Interval 923.0 to 5646.0	4868 titer Interval 2564.0 to 9243.0	1400 titer Interval 639.0 to 3063.0	4076 titer Interval 2240.0 to 7419.0	263 titer Interval 138.0 to 501.0	212 titer Interval 122.0 to 368.0	186 titer Interval 116.0 to 298.0	196 titer Interval 118.0 to 324.0	123 titer Interval 92.8 to 164.0	—
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS5	83.3 titer Interval 73.9 to 94.0	96.3 titer Interval 86.8 to 107.0	369 titer Interval 140.0 to 973.0	394 titer Interval 144.0 to 1076.0	229 titer Interval 89.8 to 586.0	616 titer Interval 200.0 to 1897.0	163 titer Interval 102.0 to 261.0	4405 titer Interval 2264.0 to 8573.0	5198 titer Interval 2647.0 to 10204.0	101 titer Interval 87.9 to 116.0	4869 titer Interval 1987.0 to 11930.0	1473 titer Interval 689.0 to 3148.0	1921 titer Interval 620.0 to 5955.0	876 titer Interval 357.0 to 2145.0	913 titer Interval 246.0 to 3386.0	100 titer Interval 71.0 to 141.0	190 titer Interval 144.0 to 251.0	90.4 titer Interval 64.8 to 126.0	81.5 titer Interval 56.5 to 118.0	99.9 titer Interval 83.2 to 120.0	—
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS6	93.9 titer Interval 78.5 to 112.0	76.1 titer Interval 69.0 to 83.9	210 titer Interval 93.6 to 471.0	187 titer Interval 93.3 to 374.0	225 titer Interval 115.0 to 441.0	325 titer Interval 139.0 to 762.0	110 titer Interval 92.3 to 131.0	5535 titer Interval 2947.0 to 10398.0	4795 titer Interval 2781.0 to 8267.0	126 titer Interval 96.5 to 164.0	727 titer Interval 297.0 to 1783.0	440 titer Interval 194.0 to 997.0	990 titer Interval 479.0 to 2045.0	468 titer Interval 254.0 to 862.0	255 titer Interval 101.0 to 646.0	89.6 titer Interval 75.5 to 106.0	82.7 titer Interval 71.8 to 95.3	60.9 titer Interval 55.5 to 66.8	60.9 titer Interval 55.5 to 66.8	96.3 titer Interval 84.2 to 110.0	—
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen LTB	91.7 titer Interval 77.3 to 109.0	71.5 titer Interval 64.4 to 79.4	914 titer Interval 436.0 to 1914.0	1883 titer Interval 1106.0 to 3206.0	2242 titer Interval 973.0 to 5163.0	1584 titer Interval 534.0 to 4697.0	396 titer Interval 242.0 to 648.0	3184 titer Interval 2007.0 to 5052.0	3450 titer Interval 1685.0 to 7065.0	82.1 titer Interval 76.8 to 87.6	2545 titer Interval 1074.0 to 6028.0	2067 titer Interval 1190.0 to 3589.0	6417 titer Interval 2978.0 to 13829.0	1435 titer Interval 854.0 to 2411.0	2475 titer Interval 1135.0 to 5400.0	704 titer Interval 387.0 to 1283.0	506 titer Interval 299.0 to 856.0	771 titer Interval 326.0 to 1823.0	509 titer Interval 276.0 to 939.0	129 titer Interval 97.7 to 171.0	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=24 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS3	1.56 fold change Interval 1.29 to 1.89	1.6 fold change Interval 1.32 to 1.94	7.38 fold change Interval 2.95 to 18.5	13.2 fold change Interval 6.07 to 28.8	21.1 fold change Interval 7.38 to 60.2	5.83 fold change Interval 1.73 to 19.7	3.67 fold change Interval 2.07 to 6.5	97.5 fold change Interval 51.5 to 185.0	74.5 fold change Interval 40.8 to 136.0	1.91 fold change Interval 0.979 to 3.73	85.2 fold change Interval 41.0 to 177.0	16.8 fold change Interval 6.96 to 40.4	38.2 fold change Interval 20.3 to 71.9	15.3 fold change Interval 6.97 to 33.4	34 fold change Interval 18.7 to 61.8	3.39 fold change Interval 1.78 to 6.46	2.95 fold change Interval 1.7 to 5.12	2.81 fold change Interval 1.75 to 4.52	2.72 fold change Interval 1.64 to 4.5	1.62 fold change Interval 1.23 to 2.13	—
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen LTB	1.47 fold change Interval 1.26 to 1.71	1.23 fold change Interval 1.1 to 1.38	16 fold change Interval 7.65 to 33.6	35.6 fold change Interval 21.3 to 59.7	39 fold change Interval 16.9 to 89.8	16.2 fold change Interval 5.48 to 48.2	4.85 fold change Interval 2.94 to 7.99	45.5 fold change Interval 28.7 to 72.2	49.3 fold change Interval 24.1 to 101.0	1.17 fold change Interval 1.1 to 1.25	44.3 fold change Interval 19.5 to 101.0	36.9 fold change Interval 21.2 to 64.2	106 fold change Interval 49.7 to 225.0	25 fold change Interval 14.9 to 41.9	41.3 fold change Interval 18.9 to 90.0	8.8 fold change Interval 4.83 to 16.0	7.55 fold change Interval 4.46 to 12.8	12.6 fold change Interval 5.34 to 29.9	9.25 fold change Interval 5.01 to 17.1	1.91 fold change Interval 1.45 to 2.52	—
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS6	1.33 fold change Interval 1.15 to 1.53	1.28 fold change Interval 1.19 to 1.37	3.2 fold change Interval 1.41 to 7.28	2.83 fold change Interval 1.36 to 5.87	3.98 fold change Interval 2.04 to 7.76	2.96 fold change Interval 1.26 to 6.93	1.3 fold change Interval 1.11 to 1.52	65.6 fold change Interval 33.8 to 127.0	59.4 fold change Interval 34.1 to 103.0	1.43 fold change Interval 1.08 to 1.89	12.5 fold change Interval 5.1 to 30.7	7.1 fold change Interval 3.14 to 16.1	14.9 fold change Interval 7.01 to 31.6	5.84 fold change Interval 3.17 to 10.8	6 fold change Interval 2.37 to 15.2	1.38 fold change Interval 1.16 to 1.64	1.5 fold change Interval 1.31 to 1.73	1.03 fold change Interval 0.941 to 1.13	1.38 fold change Interval 1.2 to 1.57	1.24 fold change Interval 1.14 to 1.34	—
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CFA/I	1.69 fold change Interval 1.19 to 2.41	1.43 fold change Interval 1.3 to 1.58	17.5 fold change Interval 6.49 to 47.3	31.9 fold change Interval 8.14 to 125.0	9.24 fold change Interval 2.81 to 30.4	11.3 fold change Interval 3.45 to 36.8	4.26 fold change Interval 2.07 to 8.78	97 fold change Interval 48.6 to 193.0	73.6 fold change Interval 46.6 to 116.0	1.11 fold change Interval 0.981 to 1.26	82.6 fold change Interval 44.5 to 153.0	22.5 fold change Interval 8.14 to 62.1	82.9 fold change Interval 33.5 to 205.0	26.9 fold change Interval 11.7 to 61.5	35.2 fold change Interval 11.3 to 110.0	2.96 fold change Interval 1.42 to 6.16	4.75 fold change Interval 2.07 to 10.9	3.67 fold change Interval 1.72 to 7.8	1.81 fold change Interval 1.17 to 2.8	1.54 fold change Interval 1.15 to 2.06	—
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen CS5	1.16 fold change Interval 1.02 to 1.31	1.26 fold change Interval 1.14 to 1.39	4.62 fold change Interval 1.68 to 12.7	5.26 fold change Interval 1.87 to 14.8	3.67 fold change Interval 1.44 to 9.37	8.92 fold change Interval 2.89 to 27.5	2.52 fold change Interval 1.58 to 4.03	44.5 fold change Interval 23.0 to 86.3	57.1 fold change Interval 28.5 to 114.0	1.05 fold change Interval 0.937 to 1.18	57.2 fold change Interval 23.2 to 141.0	20.2 fold change Interval 9.4 to 43.3	26.5 fold change Interval 8.44 to 82.9	12.3 fold change Interval 4.99 to 30.1	11.1 fold change Interval 2.98 to 41.0	1.54 fold change Interval 1.09 to 2.17	1.58 fold change Interval 1.2 to 2.09	1.48 fold change Interval 1.06 to 2.07	1.29 fold change Interval 0.897 to 1.87	1.37 fold change Interval 1.15 to 1.62	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	15 Participants	10 Participants	9 Participants	13 Participants	8 Participants	16 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CFA/I · No	—	—	—	—	—	—	—	5 Participants	10 Participants	6 Participants	6 Participants	6 Participants	16 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS3 · Yes	—	—	—	—	—	—	—	12 Participants	10 Participants	9 Participants	14 Participants	14 Participants	19 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS3 · No	—	—	—	—	—	—	—	9 Participants	12 Participants	7 Participants	6 Participants	4 Participants	16 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS5 · Yes	—	—	—	—	—	—	—	12 Participants	10 Participants	9 Participants	12 Participants	7 Participants	11 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS6 · Yes	—	—	—	—	—	—	—	11 Participants	13 Participants	8 Participants	15 Participants	6 Participants	10 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS6 · No	—	—	—	—	—	—	—	9 Participants	9 Participants	6 Participants	4 Participants	12 Participants	23 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen LTB · Yes	—	—	—	—	—	—	—	14 Participants	15 Participants	14 Participants	15 Participants	14 Participants	20 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen LTB · No	—	—	—	—	—	—	—	8 Participants	7 Participants	2 Participants	5 Participants	7 Participants	16 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS5 · No	—	—	—	—	—	—	—	8 Participants	11 Participants	7 Participants	7 Participants	8 Participants	19 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	8 Participants	6 Participants	7 Participants	10 Participants	6 Participants	8 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CFA/I · No	—	—	—	—	—	—	—	12 Participants	14 Participants	8 Participants	9 Participants	8 Participants	24 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS3 · Yes	—	—	—	—	—	—	—	6 Participants	6 Participants	4 Participants	8 Participants	8 Participants	9 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS3 · No	—	—	—	—	—	—	—	15 Participants	16 Participants	12 Participants	12 Participants	10 Participants	26 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS5 · Yes	—	—	—	—	—	—	—	6 Participants	5 Participants	9 Participants	10 Participants	2 Participants	5 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS5 · No	—	—	—	—	—	—	—	14 Participants	16 Participants	7 Participants	9 Participants	13 Participants	25 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS6 · Yes	—	—	—	—	—	—	—	5 Participants	7 Participants	5 Participants	12 Participants	3 Participants	9 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen CS6 · No	—	—	—	—	—	—	—	15 Participants	15 Participants	9 Participants	7 Participants	15 Participants	24 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen LTB · Yes	—	—	—	—	—	—	—	11 Participants	11 Participants	10 Participants	13 Participants	10 Participants	10 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen LTB · No	—	—	—	—	—	—	—	11 Participants	11 Participants	6 Participants	7 Participants	11 Participants	26 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen CFA/I	—	—	—	—	—	—	—	74.3 titer Interval 38.2 to 145.0	281 titer Interval 137.0 to 578.0	141 titer Interval 69.5 to 285.0	230 titer Interval 126.0 to 418.0	122 titer Interval 72.6 to 207.0	113 titer Interval 70.0 to 183.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen CS3	—	—	—	—	—	—	—	236 titer Interval 94.4 to 588.0	340 titer Interval 150.0 to 744.0	101 titer Interval 44.0 to 230.0	332 titer Interval 199.0 to 551.0	402 titer Interval 234.0 to 689.0	204 titer Interval 141.0 to 295.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen CS5	—	—	—	—	—	—	—	47.7 titer Interval 28.9 to 78.7	153 titer Interval 89.7 to 263.0	63.9 titer Interval 26.3 to 155.0	107 titer Interval 74.9 to 153.0	127 titer Interval 65.0 to 249.0	74 titer Interval 49.2 to 111.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen CS6	—	—	—	—	—	—	—	122 titer Interval 65.9 to 226.0	272 titer Interval 152.0 to 488.0	90.3 titer Interval 46.5 to 175.0	361 titer Interval 199.0 to 656.0	170 titer Interval 102.0 to 281.0	181 titer Interval 114.0 to 287.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen LTB	—	—	—	—	—	—	—	655 titer Interval 397.0 to 1079.0	2330 titer Interval 1140.0 to 4764.0	1500 titer Interval 838.0 to 2684.0	4159 titer Interval 1995.0 to 8672.0	1299 titer Interval 600.0 to 2813.0	839 titer Interval 549.0 to 1281.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen LTB	—	—	—	—	—	—	—	3.74 fold change Interval 1.82 to 7.68	3.71 fold change Interval 2.01 to 6.87	8.3 fold change Interval 4.18 to 16.5	8.8 fold change Interval 3.73 to 20.8	5.64 fold change Interval 2.31 to 13.8	2.58 fold change Interval 1.52 to 4.36	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen CFA/I	—	—	—	—	—	—	—	3.59 fold change Interval 2.19 to 5.9	3.36 fold change Interval 1.6 to 7.05	3.41 fold change Interval 1.31 to 8.9	5.19 fold change Interval 2.37 to 11.4	2.7 fold change Interval 1.28 to 5.73	2.1 fold change Interval 1.21 to 3.62	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen CS3	—	—	—	—	—	—	—	2.98 fold change Interval 1.8 to 4.92	2.57 fold change Interval 1.32 to 5.0	2 fold change Interval 0.743 to 5.38	4.6 fold change Interval 2.18 to 9.74	3.66 fold change Interval 2.22 to 6.02	1.91 fold change Interval 1.28 to 2.84	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen CS5	—	—	—	—	—	—	—	2.47 fold change Interval 1.5 to 4.07	2.63 fold change Interval 1.42 to 4.85	3.96 fold change Interval 1.41 to 11.1	4.08 fold change Interval 2.14 to 7.77	1.78 fold change Interval 1.03 to 3.06	1.79 fold change Interval 1.12 to 2.84	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen CS6	—	—	—	—	—	—	—	1.76 fold change Interval 0.937 to 3.3	2.85 fold change Interval 1.53 to 5.31	1.4 fold change Interval 0.362 to 5.4	7.21 fold change Interval 3.44 to 15.1	1.72 fold change Interval 1.08 to 2.73	1.96 fold change Interval 1.21 to 3.18	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX LTB · No	31 Participants	40 Participants	1 Participants	3 Participants	1 Participants	0 Participants	8 Participants	0 Participants	0 Participants	13 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	4 Participants	4 Participants	5 Participants	5 Participants	28 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS5 · Yes	7 Participants	3 Participants	5 Participants	5 Participants	3 Participants	7 Participants	10 Participants	9 Participants	12 Participants	0 Participants	11 Participants	7 Participants	7 Participants	7 Participants	8 Participants	13 Participants	10 Participants	13 Participants	9 Participants	10 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX LTB · Yes	8 Participants	9 Participants	12 Participants	12 Participants	12 Participants	13 Participants	22 Participants	15 Participants	15 Participants	1 Participants	14 Participants	14 Participants	15 Participants	14 Participants	14 Participants	26 Participants	21 Participants	21 Participants	24 Participants	21 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CFA/I · No	31 Participants	46 Participants	6 Participants	4 Participants	8 Participants	5 Participants	18 Participants	3 Participants	1 Participants	14 Participants	2 Participants	5 Participants	4 Participants	3 Participants	3 Participants	16 Participants	14 Participants	14 Participants	15 Participants	34 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS5 · No	32 Participants	46 Participants	8 Participants	10 Participants	10 Participants	6 Participants	20 Participants	5 Participants	3 Participants	13 Participants	4 Participants	8 Participants	8 Participants	8 Participants	7 Participants	17 Participants	15 Participants	13 Participants	20 Participants	39 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CFA/I · Yes	8 Participants	3 Participants	7 Participants	11 Participants	5 Participants	8 Participants	12 Participants	12 Participants	14 Participants	0 Participants	13 Participants	10 Participants	11 Participants	12 Participants	12 Participants	14 Participants	11 Participants	12 Participants	14 Participants	15 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS3 · Yes	8 Participants	5 Participants	7 Participants	6 Participants	5 Participants	6 Participants	15 Participants	14 Participants	13 Participants	3 Participants	14 Participants	12 Participants	12 Participants	10 Participants	13 Participants	17 Participants	13 Participants	12 Participants	14 Participants	14 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS3 · No	31 Participants	44 Participants	6 Participants	9 Participants	8 Participants	7 Participants	15 Participants	1 Participants	1 Participants	11 Participants	1 Participants	3 Participants	3 Participants	5 Participants	2 Participants	13 Participants	12 Participants	14 Participants	15 Participants	35 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS6 · Yes	6 Participants	3 Participants	6 Participants	5 Participants	3 Participants	5 Participants	11 Participants	8 Participants	11 Participants	0 Participants	5 Participants	12 Participants	8 Participants	8 Participants	5 Participants	9 Participants	9 Participants	11 Participants	12 Participants	14 Participants	—
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS6 · No	33 Participants	46 Participants	7 Participants	10 Participants	10 Participants	8 Participants	19 Participants	5 Participants	4 Participants	13 Participants	10 Participants	3 Participants	7 Participants	7 Participants	10 Participants	21 Participants	16 Participants	15 Participants	17 Participants	35 Participants	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS5 · Yes	2 Participants	0 Participants	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants	6 Participants	6 Participants	0 Participants	6 Participants	6 Participants	3 Participants	0 Participants	4 Participants	8 Participants	5 Participants	7 Participants	6 Participants	5 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS5 · No	37 Participants	49 Participants	11 Participants	12 Participants	11 Participants	11 Participants	27 Participants	8 Participants	8 Participants	13 Participants	9 Participants	9 Participants	12 Participants	15 Participants	11 Participants	22 Participants	20 Participants	19 Participants	23 Participants	44 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CFA/I · Yes	4 Participants	2 Participants	3 Participants	4 Participants	3 Participants	4 Participants	9 Participants	7 Participants	6 Participants	0 Participants	4 Participants	5 Participants	5 Participants	10 Participants	11 Participants	9 Participants	6 Participants	9 Participants	7 Participants	10 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CFA/I · No	35 Participants	47 Participants	10 Participants	11 Participants	10 Participants	9 Participants	21 Participants	8 Participants	9 Participants	14 Participants	11 Participants	10 Participants	10 Participants	5 Participants	4 Participants	21 Participants	19 Participants	17 Participants	22 Participants	39 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS3 · Yes	4 Participants	1 Participants	5 Participants	3 Participants	4 Participants	4 Participants	8 Participants	11 Participants	10 Participants	2 Participants	12 Participants	8 Participants	6 Participants	3 Participants	7 Participants	10 Participants	7 Participants	5 Participants	10 Participants	5 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS3 · No	35 Participants	48 Participants	8 Participants	12 Participants	9 Participants	9 Participants	22 Participants	4 Participants	4 Participants	12 Participants	3 Participants	7 Participants	9 Participants	12 Participants	8 Participants	20 Participants	18 Participants	21 Participants	19 Participants	44 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS6 · Yes	4 Participants	1 Participants	3 Participants	1 Participants	1 Participants	3 Participants	4 Participants	4 Participants	5 Participants	0 Participants	3 Participants	6 Participants	4 Participants	2 Participants	2 Participants	2 Participants	4 Participants	7 Participants	5 Participants	7 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS6 · No	35 Participants	48 Participants	10 Participants	14 Participants	12 Participants	10 Participants	26 Participants	9 Participants	10 Participants	13 Participants	12 Participants	9 Participants	11 Participants	13 Participants	13 Participants	28 Participants	21 Participants	19 Participants	24 Participants	42 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX LTB · Yes	4 Participants	6 Participants	9 Participants	11 Participants	10 Participants	13 Participants	17 Participants	13 Participants	14 Participants	0 Participants	11 Participants	14 Participants	14 Participants	12 Participants	14 Participants	21 Participants	17 Participants	18 Participants	22 Participants	13 Participants	—
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX LTB · No	35 Participants	43 Participants	4 Participants	4 Participants	3 Participants	0 Participants	13 Participants	2 Participants	1 Participants	14 Participants	4 Participants	1 Participants	1 Participants	3 Participants	1 Participants	9 Participants	8 Participants	8 Participants	7 Participants	36 Participants	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS3	141 titer Interval 100.0 to 197.0	237 titer Interval 189.0 to 297.0	318 titer Interval 132.0 to 768.0	590 titer Interval 384.0 to 907.0	245 titer Interval 115.0 to 526.0	260 titer Interval 103.0 to 656.0	105 titer Interval 61.2 to 181.0	243 titer Interval 162.0 to 363.0	229 titer Interval 153.0 to 344.0	53.1 titer Interval 31.1 to 90.6	991 titer Interval 684.0 to 1437.0	529 titer Interval 222.0 to 1260.0	475 titer Interval 315.0 to 718.0	483 titer Interval 309.0 to 754.0	1299 titer Interval 752.0 to 2244.0	140 titer Interval 80.8 to 242.0	77.6 titer Interval 46.5 to 130.0	45.1 titer Interval 30.1 to 67.6	111 titer Interval 74.0 to 167.0	53.8 titer Interval 39.9 to 72.7	—
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CFA/I	115 titer Interval 81.9 to 162.0	265 titer Interval 223.0 to 315.0	368 titer Interval 148.0 to 919.0	532 titer Interval 224.0 to 1263.0	163 titer Interval 80.1 to 334.0	189 titer Interval 72.0 to 496.0	111 titer Interval 64.0 to 192.0	74.4 titer Interval 48.9 to 113.0	57.8 titer Interval 39.6 to 94.4	20 titer Interval 17.4 to 23.0	665 titer Interval 392.0 to 1127.0	692 titer Interval 414.0 to 1158.0	1036 titer Interval 569.0 to 1887.0	669 titer Interval 330.0 to 1356.0	677 titer Interval 269.0 to 1705.0	133 titer Interval 66.3 to 267.0	164 titer Interval 83.3 to 322.0	63.4 titer Interval 28.8 to 140.0	98.4 titer Interval 65.8 to 147.0	59.2 titer Interval 43.2 to 81.3	—
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS5	96.6 titer Interval 67.3 to 139.0	123 titer Interval 91.7 to 166.0	76.1 titer Interval 37.2 to 156.0	191 titer Interval 132.0 to 277.0	298 titer Interval 219.0 to 405.0	203 titer Interval 136.0 to 305.0	67.3 titer Interval 46.4 to 97.6	35.3 titer Interval 21.7 to 57.4	42.1 titer Interval 28.9 to 61.3	13.6 titer Interval 9.92 to 18.7	147 titer Interval 87.9 to 247.0	131 titer Interval 65.2 to 263.0	402 titer Interval 290.0 to 558.0	317 titer Interval 225.0 to 447.0	194 titer Interval 111.0 to 339.0	78.9 titer Interval 53.3 to 117.0	67 titer Interval 43.6 to 103.0	57.2 titer Interval 37.4 to 87.5	129 titer Interval 94.7 to 176.0	58.9 titer Interval 43.5 to 79.8	—
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS6	231 titer Interval 162.0 to 328.0	371 titer Interval 304.0 to 453.0	430 titer Interval 241.0 to 770.0	269 titer Interval 163.0 to 444.0	230 titer Interval 144.0 to 369.0	297 titer Interval 156.0 to 565.0	110 titer Interval 81.2 to 150.0	84.8 titer Interval 55.9 to 129.0	72.1 titer Interval 42.1 to 123.0	20.7 titer Interval 14.4 to 29.8	531 titer Interval 304.0 to 926.0	694 titer Interval 416.0 to 1157.0	508 titer Interval 286.0 to 904.0	424 titer Interval 253.0 to 713.0	450 titer Interval 272.0 to 747.0	137 titer Interval 91.5 to 206.0	162 titer Interval 115.0 to 228.0	74 titer Interval 46.6 to 118.0	124 titer Interval 98.0 to 156.0	93.8 titer Interval 71.7 to 123.0	—
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX LTB	89.3 titer Interval 66.0 to 121.0	67.3 titer Interval 50.0 to 90.6	518 titer Interval 188.0 to 1425.0	352 titer Interval 260.0 to 476.0	915 titer Interval 458.0 to 1830.0	1439 titer Interval 882.0 to 2347.0	253 titer Interval 131.0 to 489.0	277 titer Interval 190.0 to 404.0	390 titer Interval 180.0 to 842.0	10.1 titer Interval 6.01 to 16.9	791 titer Interval 455.0 to 1374.0	940 titer Interval 515.0 to 1715.0	568 titer Interval 364.0 to 887.0	386 titer Interval 209.0 to 715.0	469 titer Interval 260.0 to 847.0	1165 titer Interval 699.0 to 1941.0	723 titer Interval 390.0 to 1342.0	442 titer Interval 199.0 to 983.0	403 titer Interval 195.0 to 834.0	90.8 titer Interval 58.9 to 140.0	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CFA/I	1.28 fold change Interval 0.992 to 1.65	1.19 fold change Interval 1.04 to 1.37	2.4 fold change Interval 1.47 to 3.92	2.59 fold change Interval 1.49 to 4.51	1.68 fold change Interval 0.741 to 3.8	2.94 fold change Interval 1.6 to 5.41	2.02 fold change Interval 1.3 to 3.15	3.34 fold change Interval 2.34 to 4.77	3.46 fold change Interval 2.44 to 4.9	1.2 fold change Interval 1.06 to 1.36	2.92 fold change Interval 2.01 to 4.25	3.52 fold change Interval 2.28 to 5.44	3.21 fold change Interval 1.87 to 5.5	5.65 fold change Interval 3.02 to 10.6	6.84 fold change Interval 2.69 to 17.4	2.2 fold change Interval 1.43 to 3.4	1.96 fold change Interval 1.27 to 3.02	3.08 fold change Interval 1.59 to 6.0	1.81 fold change Interval 1.3 to 2.53	1.62 fold change Interval 1.25 to 2.1	—
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS6	1.28 fold change Interval 0.898 to 1.84	1.23 fold change Interval 1.06 to 1.42	2.02 fold change Interval 1.25 to 3.29	1.62 fold change Interval 1.14 to 2.3	1.44 fold change Interval 1.04 to 2.0	2.17 fold change Interval 1.38 to 3.42	1.5 fold change Interval 1.06 to 2.1	2.98 fold change Interval 1.55 to 5.73	3.57 fold change Interval 2.2 to 5.81	1.23 fold change Interval 1.1 to 1.37	1.87 fold change Interval 1.13 to 3.09	3.12 fold change Interval 2.24 to 4.34	2.93 fold change Interval 1.8 to 4.77	1.92 fold change Interval 1.35 to 2.74	1.77 fold change Interval 1.18 to 2.65	1.43 fold change Interval 1.08 to 1.91	1.66 fold change Interval 1.22 to 2.26	2.08 fold change Interval 1.37 to 3.16	1.84 fold change Interval 1.38 to 2.43	1.51 fold change Interval 1.2 to 1.9	—
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS3	1.25 fold change Interval 0.937 to 1.66	1.17 fold change Interval 1.0 to 1.36	2.56 fold change Interval 1.07 to 6.09	1.96 fold change Interval 1.3 to 2.98	2.15 fold change Interval 0.881 to 5.26	2.82 fold change Interval 1.21 to 6.6	2.33 fold change Interval 1.57 to 3.47	8.54 fold change Interval 4.72 to 15.5	7.43 fold change Interval 4.09 to 13.5	1.62 fold change Interval 1.16 to 2.25	5.42 fold change Interval 3.94 to 7.46	6 fold change Interval 2.82 to 12.8	3.87 fold change Interval 2.44 to 6.13	3.16 fold change Interval 1.79 to 5.56	4.3 fold change Interval 2.34 to 7.9	2.54 fold change Interval 1.7 to 3.78	2.24 fold change Interval 1.52 to 3.31	2.06 fold change Interval 1.46 to 2.93	2.93 fold change Interval 1.8 to 4.77	1.53 fold change Interval 1.2 to 1.95	—
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX CS5	1.25 fold change Interval 0.967 to 1.6	1.12 fold change Interval 0.981 to 1.28	1.37 fold change Interval 0.65 to 2.87	1.73 fold change Interval 1.08 to 2.76	1.51 fold change Interval 0.999 to 2.28	2.28 fold change Interval 1.37 to 3.81	1.54 fold change Interval 1.11 to 2.14	2.75 fold change Interval 1.8 to 4.21	3.11 fold change Interval 2.2 to 4.41	1.03 fold change Interval 0.759 to 1.39	2.81 fold change Interval 1.87 to 4.24	3.11 fold change Interval 1.73 to 5.6	2.21 fold change Interval 1.48 to 3.31	1.62 fold change Interval 1.18 to 2.23	2.38 fold change Interval 1.29 to 4.37	1.73 fold change Interval 1.21 to 2.48	1.55 fold change Interval 0.989 to 2.44	2.4 fold change Interval 1.55 to 3.72	1.83 fold change Interval 1.4 to 2.4	1.47 fold change Interval 1.15 to 1.88	—
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX LTB	1.12 fold change Interval 0.811 to 1.53	1.41 fold change Interval 1.08 to 1.85	10.7 fold change Interval 3.9 to 29.4	5.68 fold change Interval 2.62 to 12.3	9.43 fold change Interval 4.32 to 20.6	34.8 fold change Interval 20.3 to 59.5	5.66 fold change Interval 3.18 to 10.1	20 fold change Interval 9.7 to 41.1	36 fold change Interval 14.9 to 87.1	0.994 fold change Interval 0.789 to 1.25	6.49 fold change Interval 4.0 to 10.5	20.2 fold change Interval 11.5 to 35.4	12.7 fold change Interval 8.59 to 18.8	9.6 fold change Interval 5.02 to 18.4	15.3 fold change Interval 7.22 to 32.6	9.09 fold change Interval 5.28 to 15.7	11.6 fold change Interval 5.69 to 23.6	10.8 fold change Interval 5.95 to 19.6	13 fold change Interval 6.65 to 25.5	2.14 fold change Interval 1.51 to 3.04	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen ≥Two-fold · Yes	—	—	—	—	—	—	—	11 Participants	10 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen ≥Two-fold · No	—	—	—	—	—	—	—	4 Participants	5 Participants	13 Participants	—	—	—	—	—	—	—	—	—	—	—
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen ≥Four-fold · Yes	—	—	—	—	—	—	—	5 Participants	8 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen ≥Four-fold · No	—	—	—	—	—	—	—	10 Participants	7 Participants	13 Participants	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults	—	—	—	—	—	—	—	177 titer Interval 109.0 to 287.0	166 titer Interval 92.0 to 301.0	30.9 titer Interval 17.2 to 55.7	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=15 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults	—	—	—	—	—	—	—	3.15 fold change Interval 2.27 to 4.37	4.66 fold change Interval 2.21 to 9.84	0.976 fold change Interval 0.609 to 1.56	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose ≥Two-fold · No	38 Participants	44 Participants	5 Participants	7 Participants	0 Participants	0 Participants	11 Participants	1 Participants	2 Participants	12 Participants	4 Participants	1 Participants	0 Participants	3 Participants	0 Participants	6 Participants	4 Participants	7 Participants	6 Participants	36 Participants	—
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose ≥Four-fold · Yes	0 Participants	2 Participants	3 Participants	3 Participants	6 Participants	10 Participants	14 Participants	11 Participants	13 Participants	0 Participants	6 Participants	10 Participants	11 Participants	9 Participants	8 Participants	15 Participants	16 Participants	12 Participants	13 Participants	7 Participants	—
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose ≥Four-fold · No	39 Participants	47 Participants	10 Participants	12 Participants	7 Participants	3 Participants	16 Participants	4 Participants	2 Participants	14 Participants	9 Participants	5 Participants	4 Participants	6 Participants	7 Participants	15 Participants	9 Participants	14 Participants	16 Participants	42 Participants	—
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose ≥Two-fold · Yes	1 Participants	5 Participants	8 Participants	8 Participants	13 Participants	13 Participants	19 Participants	14 Participants	13 Participants	2 Participants	11 Participants	14 Participants	15 Participants	12 Participants	15 Participants	24 Participants	21 Participants	19 Participants	23 Participants	13 Participants	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose	788 titer Interval 636.0 to 976.0	721 titer Interval 575.0 to 904.0	3644 titer Interval 1798.0 to 7387.0	2401 titer Interval 1539.0 to 3746.0	1565 titer Interval 1060.0 to 2312.0	5163 titer Interval 3144.0 to 8478.0	1314 titer Interval 747.0 to 2311.0	1582 titer Interval 989.0 to 2530.0	1125 titer Interval 589.0 to 2148.0	85.1 titer Interval 41.2 to 176.0	5700 titer Interval 3337.0 to 9736.0	5047 titer Interval 2475.0 to 10291.0	3784 titer Interval 2074.0 to 6902.0	3006 titer Interval 1708.0 to 5290.0	2470 titer Interval 1459.0 to 4179.0	3561 titer Interval 2062.0 to 6149.0	3935 titer Interval 2522.0 to 6141.0	1488 titer Interval 710.0 to 3120.0	1521 titer Interval 779.0 to 2970.0	513 titer Interval 341.0 to 772.0	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=39 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=49 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=13 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=30 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=25 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=26 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=49 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose	0.996 fold change Interval 0.893 to 1.11	1.23 fold change Interval 1.05 to 1.43	3.56 fold change Interval 1.6 to 7.91	2.21 fold change Interval 1.63 to 3.01	4.73 fold change Interval 3.18 to 7.04	8.77 fold change Interval 5.35 to 14.4	4.3 fold change Interval 2.71 to 6.81	6.53 fold change Interval 3.92 to 10.9	10.3 fold change Interval 5.69 to 18.6	1.11 fold change Interval 0.807 to 1.53	3.53 fold change Interval 2.26 to 5.49	7.57 fold change Interval 4.47 to 12.8	6.39 fold change Interval 3.83 to 10.7	5.02 fold change Interval 3.16 to 7.98	4.69 fold change Interval 3.16 to 7.98	5.64 fold change Interval 3.52 to 9.04	5.47 fold change Interval 3.42 to 8.73	5.19 fold change Interval 2.97 to 9.05	5.67 fold change Interval 3.29 to 9.77	1.74 fold change Interval 1.37 to 2.22	—

SECONDARY outcome

Timeframe: 19 days

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=13 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=37 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=12 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=49 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=14 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=15 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=49 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=24 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=26 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 1 antigen	2 Participants	0 Participants	4 Participants	2 Participants	2 Participants	1 Participants	13 Participants	4 Participants	0 Participants	0 Participants	7 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	16 Participants	10 Participants	9 Participants	14 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 5 antigens	2 Participants	7 Participants	0 Participants	5 Participants	4 Participants	5 Participants	0 Participants	0 Participants	15 Participants	15 Participants	0 Participants	12 Participants	9 Participants	11 Participants	10 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 4 antigens	6 Participants	5 Participants	2 Participants	3 Participants	3 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	5 Participants	4 Participants	3 Participants	5 Participants	0 Participants	3 Participants	2 Participants	2 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 3 antigens	1 Participants	3 Participants	1 Participants	1 Participants	5 Participants	4 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	5 Participants	7 Participants	5 Participants	7 Participants	4 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 2 antigens	1 Participants	0 Participants	3 Participants	3 Participants	1 Participants	2 Participants	7 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	7 Participants	8 Participants	10 Participants	4 Participants	6 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 1 antigen	1 Participants	0 Participants	5 Participants	0 Participants	2 Participants	0 Participants	18 Participants	5 Participants	0 Participants	0 Participants	9 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	10 Participants	3 Participants	9 Participants	13 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 0 antigens	2 Participants	0 Participants	26 Participants	0 Participants	0 Participants	0 Participants	22 Participants	9 Participants	0 Participants	0 Participants	37 Participants	0 Participants	0 Participants	0 Participants	0 Participants	7 Participants	3 Participants	2 Participants	4 Participants	4 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 5 antigens	2 Participants	5 Participants	0 Participants	1 Participants	3 Participants	3 Participants	0 Participants	0 Participants	15 Participants	15 Participants	0 Participants	11 Participants	4 Participants	10 Participants	5 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 4 antigens	2 Participants	5 Participants	0 Participants	3 Participants	3 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	9 Participants	4 Participants	6 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 3 antigens	5 Participants	4 Participants	0 Participants	4 Participants	4 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	6 Participants	3 Participants	5 Participants	5 Participants	2 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 2 antigens	0 Participants	1 Participants	3 Participants	2 Participants	3 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	4 Participants	4 Participants	6 Participants	5 Participants	7 Participants	—
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 0 antigens	2 Participants	0 Participants	30 Participants	0 Participants	0 Participants	0 Participants	33 Participants	10 Participants	0 Participants	0 Participants	41 Participants	0 Participants	0 Participants	0 Participants	0 Participants	11 Participants	6 Participants	3 Participants	7 Participants	6 Participants	—

SECONDARY outcome

Timeframe: 19 days

Population: Participants with results for all antigens (CFA/I, CS3, CS5, CS6, LTB) tested for.

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo n=13 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=39 Participants 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=13 Participants 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=13 Participants 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=49 Participants 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=13 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=13 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=14 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=49 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=15 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) n=30 Participants 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=25 Participants 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=26 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=29 Participants 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 5 antigens	4 Participants	3 Participants	2 Participants	2 Participants	2 Participants	1 Participants	4 Participants	0 Participants	5 Participants	8 Participants	1 Participants	4 Participants	5 Participants	5 Participants	3 Participants	5 Participants	6 Participants	6 Participants	9 Participants	7 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 5 antigens	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	3 Participants	3 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 4 antigens	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants	4 Participants	0 Participants	4 Participants	5 Participants	0 Participants	6 Participants	3 Participants	2 Participants	6 Participants	6 Participants	2 Participants	2 Participants	1 Participants	2 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 3 antigens	1 Participants	7 Participants	2 Participants	3 Participants	2 Participants	3 Participants	5 Participants	0 Participants	3 Participants	0 Participants	1 Participants	4 Participants	5 Participants	5 Participants	3 Participants	2 Participants	8 Participants	2 Participants	0 Participants	5 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 2 antigens	2 Participants	2 Participants	2 Participants	4 Participants	4 Participants	3 Participants	7 Participants	1 Participants	0 Participants	0 Participants	4 Participants	0 Participants	1 Participants	2 Participants	1 Participants	4 Participants	5 Participants	6 Participants	8 Participants	3 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 1 antigen	4 Participants	0 Participants	9 Participants	2 Participants	3 Participants	4 Participants	9 Participants	2 Participants	1 Participants	1 Participants	7 Participants	1 Participants	1 Participants	1 Participants	1 Participants	7 Participants	7 Participants	8 Participants	4 Participants	9 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Two-fold · 0 antigens	0 Participants	0 Participants	22 Participants	0 Participants	1 Participants	1 Participants	20 Participants	10 Participants	0 Participants	0 Participants	36 Participants	0 Participants	0 Participants	0 Participants	1 Participants	6 Participants	2 Participants	1 Participants	4 Participants	3 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 4 antigens	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants	0 Participants	4 Participants	2 Participants	0 Participants	0 Participants	4 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 3 antigens	2 Participants	5 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	4 Participants	1 Participants	4 Participants	5 Participants	2 Participants	4 Participants	2 Participants	5 Participants	2 Participants	4 Participants	2 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 2 antigens	2 Participants	6 Participants	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants	0 Participants	1 Participants	6 Participants	2 Participants	9 Participants	2 Participants	3 Participants	5 Participants	5 Participants	7 Participants	5 Participants	5 Participants	3 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 1 antigen	7 Participants	2 Participants	4 Participants	3 Participants	7 Participants	5 Participants	11 Participants	2 Participants	5 Participants	0 Participants	3 Participants	1 Participants	4 Participants	7 Participants	5 Participants	11 Participants	8 Participants	13 Participants	5 Participants	15 Participants	—
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects ≥Four-fold · 0 antigens	0 Participants	0 Participants	31 Participants	3 Participants	3 Participants	3 Participants	28 Participants	11 Participants	0 Participants	1 Participants	43 Participants	0 Participants	0 Participants	0 Participants	1 Participants	9 Participants	7 Participants	3 Participants	8 Participants	4 Participants	—

SECONDARY outcome

Timeframe: 7 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	8 Participants	2 Participants	3 Participants	10 Participants	7 Participants	6 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CFA/I · No	—	—	—	—	—	—	—	8 Participants	11 Participants	8 Participants	6 Participants	6 Participants	15 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS3 · Yes	—	—	—	—	—	—	—	4 Participants	2 Participants	4 Participants	10 Participants	9 Participants	8 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS3 · No	—	—	—	—	—	—	—	13 Participants	13 Participants	8 Participants	7 Participants	7 Participants	18 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS5 · Yes	—	—	—	—	—	—	—	5 Participants	2 Participants	4 Participants	8 Participants	5 Participants	4 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS5 · No	—	—	—	—	—	—	—	10 Participants	12 Participants	8 Participants	8 Participants	9 Participants	15 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS6 · Yes	—	—	—	—	—	—	—	6 Participants	3 Participants	1 Participants	10 Participants	4 Participants	6 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS6 · No	—	—	—	—	—	—	—	11 Participants	11 Participants	9 Participants	6 Participants	13 Participants	17 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen LTB · No	—	—	—	—	—	—	—	10 Participants	10 Participants	7 Participants	7 Participants	9 Participants	20 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen LTB · Yes	—	—	—	—	—	—	—	8 Participants	3 Participants	5 Participants	10 Participants	9 Participants	7 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	4 Participants	1 Participants	1 Participants	7 Participants	3 Participants	4 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CFA/I · No	—	—	—	—	—	—	—	12 Participants	12 Participants	10 Participants	9 Participants	10 Participants	17 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS3 · Yes	—	—	—	—	—	—	—	2 Participants	0 Participants	1 Participants	6 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS5 · Yes	—	—	—	—	—	—	—	1 Participants	1 Participants	4 Participants	4 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS5 · No	—	—	—	—	—	—	—	14 Participants	13 Participants	8 Participants	12 Participants	14 Participants	17 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS6 · Yes	—	—	—	—	—	—	—	3 Participants	0 Participants	1 Participants	7 Participants	1 Participants	5 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS6 · No	—	—	—	—	—	—	—	14 Participants	14 Participants	9 Participants	9 Participants	16 Participants	18 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen LTB · Yes	—	—	—	—	—	—	—	4 Participants	2 Participants	3 Participants	7 Participants	5 Participants	5 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen LTB · No	—	—	—	—	—	—	—	14 Participants	11 Participants	9 Participants	10 Participants	13 Participants	22 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen CS3 · No	—	—	—	—	—	—	—	15 Participants	15 Participants	11 Participants	11 Participants	14 Participants	24 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen CFA/I	—	—	—	—	—	—	—	49.6 titer Interval 20.2 to 122.0	94.7 titer Interval 35.7 to 251.0	53.8 titer Interval 19.3 to 150.0	125 titer Interval 59.8 to 260.0	70.6 titer Interval 42.1 to 118.0	57.1 titer Interval 28.7 to 114.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen CS3	—	—	—	—	—	—	—	111 titer Interval 45.4 to 270.0	94.7 titer Interval 35.7 to 251.0	53.8 titer Interval 19.3 to 150.0	125 titer Interval 59.8 to 260.0	70.6 titer Interval 42.1 to 118.0	57.1 titer Interval 28.7 to 114.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen CS5	—	—	—	—	—	—	—	27.8 titer Interval 15.8 to 48.8	65 titer Interval 30.9 to 137.0	19.5 titer Interval 10.1 to 37.8	60.7 titer Interval 37.1 to 99.3	59.8 titer Interval 32.3 to 111.0	35.6 titer Interval 22.3 to 56.9	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen LTB	—	—	—	—	—	—	—	281 titer Interval 154.0 to 511.0	474 titer Interval 129.0 to 1747.0	345 titer Interval 160.0 to 745.0	1249 titer Interval 471.0 to 3311.0	536 titer Interval 235.0 to 1219.0	448 titer Interval 264.0 to 762.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen CS6	—	—	—	—	—	—	—	72 titer Interval 39.7 to 130.0	80.7 titer Interval 38.7 to 168.0	36.3 titer Interval 20.1 to 65.6	187 titer Interval 84.0 to 415.0	101 titer Interval 62.7 to 164.0	101 titer Interval 51.1 to 198.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen CFA/I	—	—	—	—	—	—	—	2.05 fold change Interval 1.16 to 3.63	0.98 fold change Interval 0.447 to 2.15	1.12 fold change Interval 0.418 to 3.02	2.92 fold change Interval 1.24 to 6.88	1.53 fold change Interval 0.708 to 3.29	1.07 fold change Interval 0.456 to 2.51	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen CS5	—	—	—	—	—	—	—	1.37 fold change Interval 0.9 to 2.09	0.981 fold change Interval 0.594 to 1.62	1.19 fold change Interval 0.496 to 2.85	2.22 fold change Interval 1.16 to 4.26	0.793 fold change Interval 0.383 to 1.64	0.841 fold change Interval 0.478 to 1.48	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen CS6	—	—	—	—	—	—	—	1.09 fold change Interval 0.471 to 2.51	0.718 fold change Interval 0.424 to 1.22	0.529 fold change Interval 0.126 to 2.23	3.75 fold change Interval 1.51 to 9.32	1.02 fold change Interval 0.617 to 1.7	1.09 fold change Interval 0.479 to 2.49	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen LTB	—	—	—	—	—	—	—	1.63 fold change Interval 0.718 to 3.68	0.937 fold change Interval 0.523 to 1.68	1.76 fold change Interval 0.941 to 3.3	2.54 fold change Interval 1.06 to 6.09	2.01 fold change Interval 0.745 to 5.4	1.1 fold change Interval 0.601 to 2.03	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen CS3	—	—	—	—	—	—	—	1.32 fold change Interval 0.715 to 2.42	0.587 fold change Interval 0.373 to 0.925	0.884 fold change Interval 0.401 to 1.95	2.71 fold change Interval 1.11 to 6.64	1.73 fold change Interval 0.975 to 3.07	0.989 fold change Interval 0.613 to 1.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 19

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	8 Participants	7 Participants	4 Participants	8 Participants	5 Participants	10 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CFA/I · No	—	—	—	—	—	—	—	12 Participants	13 Participants	11 Participants	11 Participants	9 Participants	22 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS3 · Yes	—	—	—	—	—	—	—	5 Participants	7 Participants	5 Participants	7 Participants	8 Participants	9 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS5 · Yes	—	—	—	—	—	—	—	6 Participants	8 Participants	6 Participants	8 Participants	4 Participants	8 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS6 · Yes	—	—	—	—	—	—	—	6 Participants	7 Participants	4 Participants	8 Participants	5 Participants	8 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS6 · No	—	—	—	—	—	—	—	14 Participants	15 Participants	10 Participants	11 Participants	13 Participants	25 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen LTB · No	—	—	—	—	—	—	—	10 Participants	11 Participants	5 Participants	7 Participants	10 Participants	21 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS3 · No	—	—	—	—	—	—	—	16 Participants	15 Participants	11 Participants	13 Participants	10 Participants	26 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS5 · No	—	—	—	—	—	—	—	14 Participants	13 Participants	10 Participants	11 Participants	11 Participants	22 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen LTB · Yes	—	—	—	—	—	—	—	12 Participants	11 Participants	11 Participants	13 Participants	11 Participants	15 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	5 Participants	2 Participants	4 Participants	6 Participants	4 Participants	4 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CFA/I · No	—	—	—	—	—	—	—	15 Participants	18 Participants	11 Participants	13 Participants	10 Participants	28 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS3 · Yes	—	—	—	—	—	—	—	2 Participants	4 Participants	3 Participants	5 Participants	3 Participants	3 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS3 · No	—	—	—	—	—	—	—	19 Participants	18 Participants	13 Participants	15 Participants	15 Participants	32 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS5 · Yes	—	—	—	—	—	—	—	3 Participants	3 Participants	4 Participants	6 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS5 · No	—	—	—	—	—	—	—	17 Participants	18 Participants	12 Participants	13 Participants	14 Participants	27 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS6 · Yes	—	—	—	—	—	—	—	0 Participants	5 Participants	2 Participants	6 Participants	1 Participants	7 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen LTB · Yes	—	—	—	—	—	—	—	5 Participants	5 Participants	8 Participants	7 Participants	9 Participants	8 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen CS6 · No	—	—	—	—	—	—	—	20 Participants	17 Participants	12 Participants	13 Participants	17 Participants	26 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen LTB · No	—	—	—	—	—	—	—	17 Participants	17 Participants	8 Participants	13 Participants	12 Participants	28 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen CFA/I	—	—	—	—	—	—	—	37.3 titer Interval 18.3 to 76.2	99.1 titer Interval 57.6 to 170.0	40.2 titer Interval 16.1 to 100.0	102 titer Interval 50.2 to 209.0	48.9 titer Interval 21.6 to 111.0	66.3 titer Interval 43.7 to 100.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen CS3	—	—	—	—	—	—	—	107 titer Interval 47.8 to 240.0	158 titer Interval 75.3 to 330.0	48.7 titer Interval 17.1 to 139.0	136 titer Interval 74.6 to 246.0	166 titer Interval 94.9 to 292.0	118 titer Interval 83.1 to 166.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen CS5	—	—	—	—	—	—	—	27.8 titer Interval 16.4 to 47.1	72.7 titer Interval 40.1 to 132.0	22.1 titer Interval 7.04 to 69.6	50.5 titer Interval 34.3 to 74.3	63.5 titer Interval 27.7 to 146.0	45.8 titer Interval 33.0 to 63.4	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen CS6	—	—	—	—	—	—	—	62.2 titer Interval 33.2 to 117.0	135 titer Interval 68.4 to 268.0	29.8 titer Interval 11.5 to 77.7	121 titer Interval 57.8 to 252.0	94.8 titer Interval 60.0 to 150.0	110 titer Interval 71.7 to 170.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen LTB	—	—	—	—	—	—	—	306 titer Interval 171.0 to 549.0	1246 titer Interval 627.0 to 2475.0	587 titer Interval 202.0 to 1707.0	1507 titer Interval 639.0 to 3559.0	838 titer Interval 390.0 to 1802.0	533 titer Interval 317.0 to 897.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 19 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen CFA/I	—	—	—	—	—	—	—	1.81 fold change Interval 1.12 to 2.91	1.18 fold change Interval 0.627 to 2.23	0.975 fold change Interval 0.292 to 3.25	2.31 fold change Interval 1.16 to 4.59	1.08 fold change Interval 0.366 to 3.18	1.23 fold change Interval 0.78 to 1.94	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen CS3	—	—	—	—	—	—	—	1.36 fold change Interval 0.946 to 1.94	1.19 fold change Interval 0.641 to 2.22	0.97 fold change Interval 0.31 to 3.04	1.88 fold change Interval 0.923 to 3.84	1.52 fold change Interval 0.82 to 2.8	1.1 fold change Interval 0.754 to 1.61	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen CS5	—	—	—	—	—	—	—	1.44 fold change Interval 0.848 to 2.44	1.24 fold change Interval 0.599 to 2.58	1.37 fold change Interval 0.423 to 4.44	1.92 fold change Interval 0.991 to 3.71	0.888 fold change Interval 0.408 to 1.93	1.1 fold change Interval 0.71 to 1.72	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen CS6	—	—	—	—	—	—	—	0.896 fold change Interval 0.529 to 1.52	1.42 fold change Interval 0.655 to 3.07	0.457 fold change Interval 0.109 to 1.92	2.41 fold change Interval 1.09 to 5.32	0.96 fold change Interval 0.533 to 1.73	1.2 fold change Interval 0.739 to 1.94	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen LTB	—	—	—	—	—	—	—	1.75 fold change Interval 0.809 to 3.77	1.99 fold change Interval 0.987 to 4.0	3.25 fold change Interval 1.03 to 10.2	3.19 fold change Interval 1.52 to 6.69	3.64 fold change Interval 1.45 to 9.12	1.64 fold change Interval 0.904 to 2.96	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	7 Participants	6 Participants	5 Participants	10 Participants	5 Participants	10 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CFA/I · No	—	—	—	—	—	—	—	5 Participants	10 Participants	6 Participants	8 Participants	4 Participants	16 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS3 · Yes	—	—	—	—	—	—	—	5 Participants	4 Participants	5 Participants	11 Participants	8 Participants	14 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS3 · No	—	—	—	—	—	—	—	10 Participants	12 Participants	7 Participants	8 Participants	4 Participants	13 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS5 · Yes	—	—	—	—	—	—	—	5 Participants	4 Participants	4 Participants	9 Participants	3 Participants	5 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS5 · No	—	—	—	—	—	—	—	8 Participants	12 Participants	8 Participants	9 Participants	5 Participants	18 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS6 · Yes	—	—	—	—	—	—	—	5 Participants	7 Participants	3 Participants	10 Participants	4 Participants	6 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS6 · No	—	—	—	—	—	—	—	9 Participants	9 Participants	7 Participants	8 Participants	5 Participants	19 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen LTB · Yes	—	—	—	—	—	—	—	8 Participants	8 Participants	10 Participants	12 Participants	9 Participants	10 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen LTB · No	—	—	—	—	—	—	—	8 Participants	7 Participants	2 Participants	7 Participants	5 Participants	18 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CFA/I · Yes	—	—	—	—	—	—	—	4 Participants	4 Participants	4 Participants	6 Participants	5 Participants	4 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CFA/I · No	—	—	—	—	—	—	—	8 Participants	12 Participants	7 Participants	12 Participants	4 Participants	22 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS3 · Yes	—	—	—	—	—	—	—	2 Participants	4 Participants	1 Participants	6 Participants	5 Participants	8 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS3 · No	—	—	—	—	—	—	—	13 Participants	12 Participants	11 Participants	13 Participants	7 Participants	19 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS5 · Yes	—	—	—	—	—	—	—	3 Participants	3 Participants	4 Participants	7 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS5 · No	—	—	—	—	—	—	—	10 Participants	13 Participants	8 Participants	11 Participants	7 Participants	20 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS6 · Yes	—	—	—	—	—	—	—	3 Participants	4 Participants	2 Participants	7 Participants	2 Participants	4 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen CS6 · No	—	—	—	—	—	—	—	11 Participants	12 Participants	8 Participants	11 Participants	7 Participants	21 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen LTB · No	—	—	—	—	—	—	—	9 Participants	10 Participants	6 Participants	8 Participants	7 Participants	21 Participants	—	—	—	—	—	—	—	—
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen LTB · Yes	—	—	—	—	—	—	—	7 Participants	5 Participants	6 Participants	11 Participants	7 Participants	7 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen CS3	—	—	—	—	—	—	—	106 titer Interval 40.1 to 281.0	271 titer Interval 105.0 to 699.0	57.5 titer Interval 32.6 to 101.0	223 titer Interval 120.0 to 413.0	373 titer Interval 158.0 to 877.0	181 titer Interval 121.0 to 273.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen CS6	—	—	—	—	—	—	—	57.8 titer Interval 29.0 to 115.0	145 titer Interval 72.2 to 293.0	44.2 titer Interval 13.0 to 150.0	138 titer Interval 71.8 to 266.0	163 titer Interval 55.3 to 484.0	86.1 titer Interval 45.8 to 162.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen LTB	—	—	—	—	—	—	—	517 titer Interval 264.0 to 1010.0	2151 titer Interval 875.0 to 5291.0	911 titer Interval 364.0 to 2277.0	2231 titer Interval 1018.0 to 4888.0	1128 titer Interval 376.0 to 3381.0	391 titer Interval 230.0 to 665.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen CS5	—	—	—	—	—	—	—	28.8 titer Interval 15.4 to 281.0	271 titer Interval 105.0 to 699.0	57.5 titer Interval 32.6 to 101.0	223 titer Interval 120.0 to 413.0	373 titer Interval 158.0 to 877.0	181 titer Interval 121.0 to 273.0	—	—	—	—	—	—	—	—
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen CFA/I	—	—	—	—	—	—	—	52.4 titer Interval 18.4 to 149.0	178 titer Interval 76.7 to 414.0	72.6 titer Interval 22.2 to 237.0	126 titer Interval 57.6 to 274.0	136 titer Interval 90.9 to 204.0	61.8 titer Interval 34.4 to 111.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.

Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin

Outcome measures

Outcome measures
Measure	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	Adult: ETVAX (Full) n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=23 Participants Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=16 Participants Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=20 Participants 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=21 Participants 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=37 Participants 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen CFA/I	—	—	—	—	—	—	—	2.74 fold change Interval 1.16 to 6.47	2.35 fold change Interval 0.93 to 5.92	1.46 fold change Interval 0.38 to 5.92	2.73 fold change Interval 1.18 to 6.34	2.35 fold change Interval 0.941 to 5.88	1.32 fold change Interval 0.767 to 2.28	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen CS3	—	—	—	—	—	—	—	1.28 fold change Interval 0.512 to 3.2	1.59 fold change Interval 0.528 to 4.81	1.02 fold change Interval 0.408 to 2.55	2.83 fold change Interval 1.33 to 6.04	3.08 fold change Interval 1.69 to 5.61	1.71 fold change Interval 1.02 to 2.86	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen CS5	—	—	—	—	—	—	—	1.63 fold change Interval 0.857 to 3.1	1.61 fold change Interval 0.757 to 3.42	1.42 fold change Interval 0.41 to 4.91	1.85 fold change Interval 0.929 to 3.7	1.18 fold change Interval 0.484 to 2.87	1.16 fold change Interval 0.618 to 2.17	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen CS6	—	—	—	—	—	—	—	0.882 fold change Interval 0.401 to 1.94	1.5 fold change Interval 0.723 to 3.1	0.709 fold change Interval 0.18 to 2.8	2.6 fold change Interval 1.32 to 5.15	1.39 fold change Interval 0.593 to 3.24	1.05 fold change Interval 0.575 to 1.93	—	—	—	—	—	—	—	—
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen LTB	—	—	—	—	—	—	—	2.14 fold change Interval 0.763 to 6.01	1.92 fold change Interval 0.755 to 4.9	4.58 fold change Interval 1.79 to 11.7	5.33 fold change Interval 2.01 to 14.2	4.65 fold change Interval 1.41 to 15.3	1.19 fold change Interval 0.612 to 2.31	—	—	—	—	—	—	—	—

Adverse Events

Adult: ETVAX (Full)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adult: ETVAX (Full) + 10 ug dmLT

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adult: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

24-59 Months: ETVAX (1/4)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

24-59 Months: ETVAX (1/2)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

24-59 Months: ETVAX (Full)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

24-59 Months: ETVAX (1/2) + 2.5 ug dmLT

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

24-59 Months: ETVAX (1/2) + 5 ug dmLT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

24-59 Months: ETVAX (1/2) + 10 ug dmLT

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

24-59 Months: Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

12-23 Months: ETVAX (1/4)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

12-23 Months: ETVAX (1/2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

12-23 Months: ETVAX (1/2) + 2.5 ug dmLT

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

12-23 Months: ETVAX (1/2) + 5 ug dmLT

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

12-23 Months: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

6-11 Months: ETVAX (1/8)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

6-11 Months: ETVAX (1/4)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

6-11 Months: ETVAX (1/2)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

6-11 Months: ETVAX (1/4) + 2.5 ug dmLT

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

6-11 Month Olds: Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adult: ETVAX (Full) n=15 participants at risk Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 participants at risk Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=15 participants at risk Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 participants at risk 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=3 participants at risk 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=52 participants at risk 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 participants at risk 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 participants at risk 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 participants at risk 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 5 ug dmLT n=15 participants at risk 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=40 participants at risk 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	6-11 Months: ETVAX (1/8) n=30 participants at risk 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 participants at risk 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=30 participants at risk 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=30 participants at risk 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=30 participants at risk 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo n=50 participants at risk 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
General disorders Pyrexia	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	1.9% 1/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Musculoskeletal and connective tissue disorders Rickets	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Infections and infestations Pneumonia	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)

Other adverse events

Other adverse events
Measure	Adult: ETVAX (Full) n=15 participants at risk Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: ETVAX (Full) + 10 ug dmLT n=15 participants at risk Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14	Adult: Placebo n=15 participants at risk Adult arm (18-45 year olds) receiving a placebo on days 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	24-59 Months: ETVAX (1/4) n=15 participants at risk 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (Full) n=3 participants at risk 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 5 ug dmLT n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: ETVAX (1/2) + 10 ug dmLT n=15 participants at risk 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	24-59 Months: Placebo n=52 participants at risk 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	12-23 Months: ETVAX (1/4) n=15 participants at risk 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) n=15 participants at risk 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 2.5 ug dmLT n=15 participants at risk 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: ETVAX (1/2) + 5 ug dmLT n=15 participants at risk 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	12-23 Months: Placebo n=40 participants at risk 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water	6-11 Months: ETVAX (1/8) n=30 participants at risk 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) n=30 participants at risk 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/2) n=30 participants at risk 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Months: ETVAX (1/4) + 2.5 ug dmLT n=30 participants at risk 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT n=30 participants at risk 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14	6-11 Month Olds: Placebo n=50 participants at risk 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14 Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Investigations Alanine aminotransferase increased	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.5% 1/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.0% 1/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Blood and lymphatic system disorders Anaemia	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	1.9% 1/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	13.3% 2/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.5% 1/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Infections and infestations Bronchiolitis	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.0% 1/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Cardiac disorders Cardiac failure	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Skin and subcutaneous tissue disorders Dandruff	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.5% 1/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Eye disorders Keratitis	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Injury, poisoning and procedural complications Laceration	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	5.0% 2/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Infections and infestations Measles	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.0% 1/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Infections and infestations Nasopharyngitis	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	13.3% 2/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Injury, poisoning and procedural complications Thermal burn	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Infections and infestations Varicella	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
General disorders Pyrexia	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	20.0% 3/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.8% 2/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	20.0% 3/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.5% 1/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 2/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 2/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 2/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	10.0% 3/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	10.0% 3/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	12.0% 6/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
General disorders Vomiting	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	13.3% 2/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	66.7% 2/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	13.3% 2/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	20.0% 3/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	13.3% 2/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	13.3% 2/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	53.3% 8/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 2/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	16.7% 5/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	26.7% 8/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	20.0% 6/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	16.7% 5/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	4.0% 2/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Gastrointestinal disorders Loose stools	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	20.0% 3/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Gastrointestinal disorders Diarrhea	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/3 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	1.9% 1/52 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 1/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	20.0% 3/15 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	2.5% 1/40 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	0.00% 0/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	10.0% 3/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.7% 2/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	3.3% 1/30 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)	6.0% 3/50 • 6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)

Additional Information

Jorge Flores

PATH

Phone: (202) 822-0033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place