TABLE 4.

Local (injection site) and systemic reactions

ReactionNo. (%) of subjects with the indicated reactiona after:
1st dose2nd dose3rd dose4th dose
MenBvac (n = 229)Placebo (n = 117)MenBvac (n = 204)Placebo (n = 111)MenBvac (n = 188)Placebo (n = 105)MenBvac (n = 183)Placebo (n = 90)
Pain
    Present222 (97)113 (97)192 (94)103 (93)169 (90)88 (84)178 (97)84 (93)
    Severe45 (20)15 (13)16 (8)6 (5)10 (5)6 (6)33 (18)6 (7)
Redness
    Present107 (47)25 (21)***101 (50)14 (13)***98 (52)10 (10)***99 (54)11 (12)***
    Severe4 (2)1 (1)9 (4)07 (4)012 (7)0
Swelling
    Present116 (51)38 (32)**118 (58)28 (25)***113 (60)22 (21)***118 (64)25 (28)***
    Severe9 (4)1 (1)15 (7)09 (5)014 (8)0
Headache
    Present78 (34)33 (28)56 (27)26 (23)53 (28)19 (18)45 (25)15 (17)
    Severe4 (2)2 (2)4 (2)2 (2)4 (2)2 (2)3 (2)0
Malaise
    Present106 (46)37 (32)**77 (38)35 (32)64 (34)31 (30)75 (41)20 (22)**
    Severe10 (4)5 (4)8 (4)1 (1)4 (2)1 (1)9 (5)0
Temp
    ≥38 and <40°C11 (5)1 (1)b11 (5)0b3 (2)0b7 (4)0b
    ≥40°C00000000
  • a *, P < 0.05; **, P < 0.01; ***, P < 0.001(based on P values from Pearson's chi-square test for vaccine group differences). If any expected cell count was <1 or if >20% of the cells had an expected cell count of <5, then Fisher's exact test was used.

  • b Vaccine group difference not evaluable.