Table 5.
Proportion of participants with unsolicited adverse events within 4 weeks after vaccination
Vi-DT vaccine group |
Vi-TT vaccine group | Vi-DT vaccine lot 1 plus lot 2 plus lot 3 vs Vi-TT vaccine p value* | Vi-DT vaccine lot 1, lot 2, lot 3, and Vi-TT vaccine p value* | ||||
---|---|---|---|---|---|---|---|
All lots | Lot 1 | Lot 2 | Lot 3 | ||||
All ages | 208/1350 (15·4%; 13·6–17·4) | 63/450 (14·0%; 11·1–17·5) | 74/450 (16·4%; 3·3–20·2) | 71/450 (15·8%; 12·7–19·4) | 76/450 (16·9%; 13·7–20·6) | 0·46 | 0·65 |
Age 6 months to <2 years | 137/450 (30·4%; 26·7–34·9) | 37/150 (24·7%; 18·5–32·1) | 48/150 (32·0%; 25·1–39·8) | 52/150 (34·7%; 27·5–42·6) | 54/150 (36·0%; 28·8–43·9) | 0·21 | 0·15 |
Age 2 years to <18 years | 45/450 (10·0%; 7·6–13·1) | 17/150 (11·3%; 7·2–17·4) | 20/150 (13·3%; 8·8–19·7) | 8/150 (5·3%; 2·7–10·2) | 16/150 (10·7%; 6·7–16·6) | 0·82 | 0·12 |
Age 18 years to 45 years | 26/450 (5·8%; 4·0–8·3) | 9/150 (6·0%; 3·2–11·0) | 6/150 (4·0%; 1·9–8·5) | 11/150 (7·3%; 4·1–12·7) | 6/150 (4·0%; 1·9–8·5) | 0·40 | 0·50 |
Data are n/N (%; 95% CI), unless otherwise indicated. n=number of participants who reported events. N=total number of participants. Vi-DT=Vi polysaccharide-diphtheria toxoid. Vi-TT=Vi polysaccharide-tetanus toxoid.
p values were calculated by use of χ2 tests.