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. 2025 Feb 24;10(3):e01032-24. doi: 10.1128/msphere.01032-24

TABLE 4.

Adverse events during the investigational product administration perioda by intervention group

Parameter Intervention group Pb
Placebo LP1 LP1 + FOS LP7 LP7 + FOS
Caregiver-reported symptoms, n (%)c
 Number of participants, N 101 105 103 104 102
 Abdominal distension 0 (0) 0 (0) 1 (1.0) 1 (1.0) 1 (1.0) 0.8
 Acute diarrhea 1 (1.0) 1 (1.0) 1 (1.0) 0 (0) 0 (0) 0.7
 Persistent vomiting (≥3 times in 24 hours) 1 (1.0) 1 (1.0) 2 (1.9) 0 (0) 0 (0) 0.5
 Vomiting 2 (2.0) 1 (1.0) 3 (2.9) 1 (1.0) 1 (1.0) 0.8
 ≥6 hours since last passed urine 0 (0) 2 (1.9) 1 (1.0) 0 (0) 0 (0) 0.5
 Red or discharging umbilicus 2 (2.0) 5 (4.8) 1 (1.0) 4 (3.8) 2 (2.0) 0.5
 Skin pustules or boil 1 (1.0) 0 (0) 1 (1.0) 1 (1.0) 2 (2.0) 0.7
 Unusual skin rash or anything abnormal on skin 0 (0) 1 (1.0) 2 (1.9) 1 (1.0) 1 (1.0) 0.8
 Yellowing of skin or eyes 5 (5.0) 7 (6.7) 11 (11) 8 (7.7) 4 (3.9) 0.3
 Red/oozing/swollen eyes 3 (3.0) 4 (3.8) 6 (5.8) 1 (1.0) 5 (4.9) 0.4
 Sores inside mouth 0 (0) 0 (0) 1 (1.0) 2 (1.9) 0 (0) 0.4
 Cough 1 (1.0) 1 (1.0) 0 (0) 3 (2.9) 1 (1.0) 0.5
 Runny nose 3 (3.0) 1 (1.0) 1 (1.0) 0 (0) 2 (2.0) 0.3
 Stuffy nose 4 (4.0) 5 (4.8) 6 (5.8) 5 (4.8) 2 (2.0) 0.7
 Hot to the touch or has fever 4 (4.0) 1 (1.0) 2 (1.9) 2 (1.9) 2 (2.0) 0.7
 Other signs of illnessd 1 (1.0) 1 (1.0) 1 (1.0) 1 (1.0) 0 (0) ≥0.9
 At least one of the symptoms listed above 20 (20) 23 (22) 29 (28) 20 (19) 18 (18) 0.4
 More than one of the following: vomiting, diarrhea, and/or abdominal distension 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) NA
Study personnel-observed signs, n (%)e
 Number of visits at which an infant was examined 288 302 306 293 297
 Poor feeding (not sucking effectively)f 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) NA
 Jaundice 9 (3.1) 8 (2.6) 13 (4.2) 8 (2.7) 5 (1.7) 0.8
 Skin pustules or abscess 1 (0.3) 0 (0) 2 (0.7) 2 (0.7) 1 (0.3) 0.8
 Skin rash 0 (0) 2 (0.7) 2 (0.7) 1 (0.3) 1 (0.3) ≥0.9
 Sunken, red, oozing, or swollen eyesg 0 (0) 1 (0.3) 1 (0.3) 0 (0) 1 (0.3) ≥0.9
 Severe lower chest wall in-drawingf 0 (0) 0 (0) 0 (0) 0 (0) 1 (0.3) 0.5
 Fever (≥37.5°C)f 1 (0.3) 0 (0) 1 (0.3) 0 (0) 0 (0) 0.5
 Hypothermia (<35.5°C)f 0 (0) 0 (0) 0 (0) 1 (0.3) 0 (0) 0.3
 Convulsionsf 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) NA
 No movement, movement only with stimulation, or unconsciousf 1 (0.3) 0 (0) 0 (0) 0 (0) 0 (0) 0.09
 Other signs of illnessh 2 (0.7) 2 (0.7) 1 (0.3) 0 (0) 1 (0.3) 0.6
a

From the day after the first IP dose up to and including 3 days after the last dose.

b

P-values were based on permutation testing (see text for details). NA indicates that statistical testing of comparisons was not performed due to zero events.

c

Count (n) and percentage of infants with a symptom(s) reported at least once among all infants who received at least one IP dose.

d

Other symptoms reported by caregivers included noisy breathing, projectile vomiting, poor feeding, fast or difficult breathing, and unusually sleepy or could not wake from sleep.

e

Count (n) and percentage of visits at which the sign was observed among all visits at which the relevant examination was conducted.

f

Sign of clinical severe infection.

g

nOverall = 1,478; nPlacebo = 288; nLP1 = 300; nLP1+FOS = 304; nLP7 = 292; nLP7+FOS = 294; due to missing evaluations of sunken, red, oozing, or swollen eyes

h

Other signs of illness observed by study personnel included abdominal distension, mouth breathing, nasal discharge/rhinorrhea, umbilicus red, discolored, or discharging pus, and elevated respiratory rate.