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. 2007 Oct 22;76(1):229–238. doi: 10.1128/IAI.00977-07

TABLE 1.

Overall incidence of reactogenicity at the injection site after third vaccine dosea

Group (n) Incidence of symptomb
Skin redness
Skin swelling
Muscle induration
Preinjection Dose 1 Dose 2 Dose 3 Preinjection Dose 1 Dose 2 Dose 3 Preinjection Dose 1 Dose 2 Dose 3
Control (5) 0.60 ± 0.25 0.80 ± 0.37 0.80 ± 0.20 0.80 ± 0.20 0.20 ± 0.20 0.20 ± 0.20 0.00 ± 0.00 0.00 ± 0.00 0.20 ± 0.20 0.12 ± 0.20 1.00 ± 0.32 0.20 ± 0.20
LSA1/AS01B (8) 0.25 ± 0.25 1.25 ± 0.31 0.63 ± 0.26 0.38 ± 0.26 0.13 ± 0.13 1.38 ± 0.26 0.63 ± 0.26 0.13 ± 0.13 0.00 ± 0.00 2.38 ± 0.18 1.88 ± 0.30 1.00 ± 0.27
RTS,S/AS01B (8) 0.38 ± 0.26 1.25 ± 0.31 0.88 ± 0.30 0.50 ± 0.19 0.25 ± 0.25 1.00 ± 0.38 0.75 ± 0.49 0.38 ± 0.38 0.00 ± 0.00 2.38 ± 0.18 2.00 ± 0.27 1.25 ± 0.31
LSA1/AS01B plus RTS,S/AS01B
    LSA1 leg (8) 0.38 ± 0.18 1.13 ± 0.23 0.88 ± 0.30 0.63 ± 0.26 0.00 ± 0.00 1.38 ± 0.53 1.13 ± 0.44 0.13 ± 0.13 0.25 ± 0.16 2.63 ± 0.18 2.75 ± 0.16 2.00 ± 0.19
    RTS,S leg (8) 0.38 ± 0.18 1.00 ± 0.27 0.88 ± 0.30 0.63 ± 0.26 0.00 ± 0.00 1.00 ± 0.38 1.13 ± 0.44 0.38 ± 0.26 0.00 ± 0.00 2.25 ± 0.31 2.38 ± 0.26 1.38 ± 0.18
a

Grade 3 muscle induration was frequently observed on days 1 and 2 after the third dose of vaccine. This subsided on day 3 and disappeared on day 14.

b

Data are mean intensities ± SE for scores ranging from 0 to 3 (0, absent; 1, mild; 2, moderate; and 3, severe).