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. Author manuscript; available in PMC: 2020 Jan 21.
Published in final edited form as: Vaccine. 2018 Dec 15;37(4):602–611. doi: 10.1016/j.vaccine.2018.12.011

Table 2:

Subjects experiencing any solicited symptoms following administration of all vaccine doses

Cohorts, dmLT Dose and Routes; % with symptoms (95% CI)
1 2 3 4 5, 25 μg
1 μg 5 μg 25 μg 50 μg Sublingual Oral
Symptoms n =12 n =14 n =11 n =11 n = 16 n = 16
Any Systemic 17 29 27 9 25 31
Symptom (2, 48) (8, 58) (6, 61) (0, 41) (7, 52) (11, 59)
Fever 0 7 0 0 0 0
(0, 26) (0, 34) (0, 28) (0, 28) (0, 21) (0, 21)
Diarrhea 0 7 0 0 0 0
(0, 26) (0, 34) (0, 28) (0, 28) (0, 21) (0, 21)
Abdominal Pain 8 21 27 9 25 25
(0, 38) (5, 51) (6, 61) (0, 41) (7, 52) (7, 52)
Anorexia 17 14 18 9 19 6
(2, 48) (2, 43) (2, 52) (0, 41) (4, 46) (0, 30)
Vomiting 0 7 0 9 6 6
(0, 26) (0, 34) (0, 28) (0, 41) (0, 30) (0, 30)
Any Local Symptom 8 14 27 0 0 6
(8, 38) (2, 34) (6, 61) (0, 28) (0, 21) (0, 30)
Oral Local Reactions 8 14 27 0 0 6
(8, 38) (2, 43) (6, 61) (0, 28) (0, 21) (0, 30)
Any Symptom 17 36 36 9 25 31
(2, 48) (13, 65) (11, 69) (0, 41) (7,52) (11,59)

Cohorts 1–4 received sublingual dmLT

Denominator for percentages is the number of subjects in the safety analysis population (all subjects who received at least one dose of study product). Numbers in parenthesis represent 95% CI based on an exact binomial distribution (Clopper-Pearson)