TABLE 6

Subjects Reporting Local Reactions Within 7 Days

Local ReactionDose 1Dose 2Dose 3Toddler Dose
PCV13, % (na/Nb)PCV7, % (n/N)PCV13, % (n/N)PCV7, % (n/N)PCV13, % (n/N)PCV7, % (n/N)PCV13, % (n/N)PCV7, % (n/N)
Tenderness
    Any72.7 (192/264)72.2 (195/270)77.0 (154/200)75.9 (164/216)78.7 (140/178)80.9 (140/173)81.2 (121/149)84.4 (124/147)
    Significantc13.7 (25/182)9.2 (18/195)10.6 (13/123)11.5 (15/131)8.8 (8/91)9.3 (8/86)15.4 (10/65)12.2 (6/49)
Swelling
    Any27.4 (55/201)23.6 (51/216)31.2 (44/141)29.5 (43/146)37.9 (44/116)36.9 (38/103)44.0 (40/91)50.7 (37/73)
    Mildd23.1 (46/199)21.2 (45/212)29.8 (42/141)26.1 (37/142)35.4 (40/113)36.9 (38/103)43.3 (39/90)46.5 (33/71)
    Moderated6.8 (12/176)5.2 (10/193)5.1 (6/118)7.1 (9/126)6.6 (6/91)6.1 (5/82)14.7 (10/68)14.3 (7/49)
    Severed0.0 (0/173)0.0 (0/187)0.0 (0/116)0.0 (0/120)0.0 (0/87)0.0 (0/79)0.0 (0/59)0.0 (0/44)
Redness
    Any35.6 (72/202)32.3 (72/223)45.2 (70/155)37.8 (62/164)48.9 (64/131)50.0 (59/118)54.4 (56/103)65.5 (57/87)
    Mildd34.5 (69/200)31.4 (69/220)44.5 (69/155)37.0 (60/162)47.7 (61/128)48.7 (57/117)53.9 (55/102)63.5 (54/85)
    Moderated4.5 (8/177)2.6 (5/191)1.7 (2/117)3.2 (4/124)5.5 (5/91)5.0 (4/80)8.1 (5/62)14.0 (7/50)
    Severed0.0 (0/173)0.0 (0/186)0.0 (0/116)0.0 (0/120)0.0 (0/87)0.0 (0/79)0.0 (0/59)0.0 (0/44)
  • No differences were statistically significant; P < .05 (Fisher's exact test, 2-sided).

  • a Number of subjects who reported the specific characteristic.

  • b Number of subjects who reported “yes” for at least 1 day or “no” for all days.

  • c Present and interfered with limb movement.

  • d Mild, 0.5–2.0 cm; moderate, 2.5–7.0 cm; and severe, >7.0 cm.