Table 1.

Self-reported symptoms during 4 days after the first and second doses of oral ETEC vaccine (lot E003) or placebo

SymptomNo. (%) reported
Dose 1Dose 2
Placebo (n = 31)Vaccine (n = 33)Placebo (n = 29)Vaccine (n = 30)
Any16 (55)21 (64)15 (52)16 (53)
Diarrhea2 (7)0 (0)1 (3)0 (0)
Fever0 (0)1b (3)0 (0)0 (0)
Abdominal cramps8 (26)12 (36)7 (24)8 (27)
Nausea5 (16)4 (12)0 (0)9 (30)
Vomiting1 (3)0 (0)0 (0)5 (17)
Headache8 (26)12 (36)6 (21)7 (23)
Malaise5 (16)8 (24)2 (7)10 (33)
Loss of appetite2 (7)6 (18)2 (7)4 (13)
  • a ! (P = 0.002) and # (P = 0.021) by Fisher exact test; all the other differences were not statistically significant;

  • b 38.0°C reported on day 2 after dosing.