Table 2

Numbers of subjects with treatment-related AEs before challenge by group

MedDRA System Organ Class preferred termVaccine group (n = 36)Placebo group (n = 34)
No.%No.%
Any treatment-emergent AE related to vaccinea1747.21647.1
Gastrointestinal symptoms
    Gastrointestinal sounds abnormal822.2823.5
    Abdominal pain1027.8514.7
    Nausea1130.6411.8
    Defecation urgency822.2514.7
    Loose stools (<3 per 24 h)822.2411.8
    Diarrhea (>2 per 24 h)616.712.9
    Vomitingb719.400.0
General symptoms
    Anorexia1027.838.8
    Malaise719.4514.7
    Chills38.325.9
    Headache616.725.9
    Dizziness513.912.9
    Myalgia25.612.9
  • a AEs occurring in more than one subject.

  • b P < 0.05.