TABLE 7

Subjects Reporting Systemic Events and Antipyretic Medication Use Within 7 Days

Systemic 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)
Fever
    ≥38°C but ≤39°C24.0 (47/196)21.2 (43/203)43.2 (63/146)40.4 (61/151)39.8 (49/123)37.7 (40/106)53.5 (53/99)51.3 (39/76)
    >39°C but ≤40°C2.8 (5/177)0.0 (0/187)c2.5 (3/118)4.9 (6/123)8.5 (8/94)2.5 (2/81)6.6 (4/61)12.5 (6/48)
    >40°C0.0 (0/174)0.0 (0/187)0.0 (0/116)0.8 (1/121)0.0 (0/87)1.3 (1/80)1.7 (1/60)0.0 (0/45)
Decreased appetite54.8 (125/228)45.4 (108/238)59.9 (106/177)52.3 (91/174)59.2 (87/147)59.6 (81/136)65.5 (76/116)73.6 (81/110)
Irritability89.6 (259/289)85.9 (249/290)89.8 (212/236)91.5 (216/236)88.4 (191/216)92.2 (201/218)92.0 (183/199)93.1 (163/175)
Increased sleep79.5 (213/268)78.5 (212/270)79.3 (161/203)73.5 (147/200)71.3 (117/164)69.8 (104/149)70.4 (81/115)74.3 (81/109)
Decreased sleep45.7 (101/221)47.9 (113/236)49.1 (83/169)55.8 (96/172)60.4 (93/154)63.4 (85/134)58.4 (66/113)64.2 (61/95)
Hives1.7 (3/178)1.1 (2/188)2.5 (3/118)0.0 (0/120)4.5 (4c/89)0.0 (0d/79)4.8 (3/62)6.4 (3/47)
Use of antipyretic medication to prevent symptoms75.0 (204/272)74.8 (205/274)86.7 (202/233)83.5 (193/231)81.2 (164/202)84.1 (159/189)88.4 (145/164)90.7 (147/162)
Use of antipyretic medication to treat symptoms78.6 (202/257)71.8 (191/266)82.4 (182/221)81.9 (181/221)82.3 (167/203)85.6 (160/187)84.0 (136/162)87.7 (121/138)
  • 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 Statistically significant difference; P < .05 (Fisher's exact test, 2-sided).

  • d One report of hives was recorded in error on the e-diary of a subject in the PCV13 group; the case was actually in a subject in the PCV7 group.