TABLE 2

Adverse reactions following ingestion of vaccines or placebo

Adverse reactionNo. (%) of participants in:
Groups A1a and A2b (n = 49)Groups B1a and B2b (n = 49)Placebod (n = 99)Group Cc
Dose 1 (n = 50)Dose 2 (n = 50)
Any symptome2 (4.1)2 (4.1)8 (8.1)6 (12)4 (8.0)
Vomiting00000
Diarrheaf001 (1.0)00
Fatigue1 (2.0)1 (2.0)2 (2.0)5 (10)1 (2.0)
Loss of appetite0003 (6.0)0
Headache1 (2.0)1 (2.0)5 (5.1)4 (8.0)3 (6.0)
Abdominal pain1 (2.0)01 (1.0)1 (2.0)1 (2.0)
  • a Participants randomly allocated to subgroups A1 and B1 ingested a dose of CVD 103-HgR (∼108 CFU and ∼109 CFU, respectively) on day 0 and a dose of placebo on day 14.

  • b Participants randomly allocated to subgroups A2 and B2 (∼108 CFU and ∼109 CFU, respectively) ingested a dose of placebo on day 0 and a dose of CVD 103-HgR on day 14.

  • c Participants randomly allocated to group C ingested their first dose of Shanchol on day 0 and their second dose on day 14.

  • d Placebo represents the pooled clinical follow-up after the ingestion of placebo by the participants in groups A1, A2, B1, and B2.

  • e This analysis assessed reactogenicity for the 7 days of active follow-up after each dosing that included multiple household visits following vaccination with CVD 103-HgR and the 7 days of active follow-up that included multiple household visits following receipt of placebo.

  • f Defined as ≥4 loose stools within a 24-h period.