TABLE 2.
Frequency of volunteers experiencing AEsa
| AE | No. (%) for regimenb:
|
|||
|---|---|---|---|---|
| Day 0-14-28
|
Day 0-2-4-6
|
|||
| meCS6+ | meCS6− | meCS6+ | meCS6− | |
| Diarrheac | 0 (0) | 1 (7) | 1 (7) | 0 (0) |
| Loose stoolsd | 5 (33) | 5 (33) | 5 (33) | 5 (33) |
| Abdominal cramps | 1 (7) | 2 (13) | 4 (27) | 1 (7) |
| Nausea | 0 (0) | 4 (27) | 1 (7) | 2 (13) |
a
Limited to actively monitored events determined to be possibly, probably, or definitely related to the vaccine (determined by temporal relationship and no other clearly evident cause). No vaccine-related vomiting or fever was noted. One person in the Day 0-2-4-6 meCS6− group had a headache and malaise that were possibly vaccine related.
b
+, with adjuvant; −, without adjuvant.
c
Three or more loose liquid stools per 24 h.
d
Two or less loose or liquid stools per 24 h. Does not include subjects with diarrhea.