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TABLE 3

Overall Summary of Solicited and Unsolicited Adverse Events in Subjects 6 Through 47 Months of Age (Full Analysis Set)

Adverse Event, n (%)aUS-Licensed QIV, n (%) (n = 805)QIVc, n (%) (n = 1597)
Solicited   
 Any 517 (65.9) 997 (63.7) 
 Local 350 (44.6) 656 (41.9) 
 Systemic 358 (45.7) 681 (43.5) 
 Analgesic or antipyretic use 136 (17.3) 240 (15.3) 
Unsolicited   
 Any 207 (25.7) 418 (26.2) 
 Mild 164 (20.4) 308 (19.3) 
 Moderate 41 (5.1) 98 (6.1) 
 Severe 2 (0.2) 12 (0.8) 
 Any related 36 (4.5) 70 (4.4) 
 Any SAE 7 (0.9) 15 (0.9) 
 Related SAE 
 Deaths 2 (0.1) 
 New onset chronic disease 13 (1.6) 22 (1.4) 
 AE leading to study withdrawal 3 (0.2) 
 Medically attended AE 97 (12.0) 222 (13.9) 
Adverse Event, n (%)aUS-Licensed QIV, n (%) (n = 805)QIVc, n (%) (n = 1597)
Solicited   
 Any 517 (65.9) 997 (63.7) 
 Local 350 (44.6) 656 (41.9) 
 Systemic 358 (45.7) 681 (43.5) 
 Analgesic or antipyretic use 136 (17.3) 240 (15.3) 
Unsolicited   
 Any 207 (25.7) 418 (26.2) 
 Mild 164 (20.4) 308 (19.3) 
 Moderate 41 (5.1) 98 (6.1) 
 Severe 2 (0.2) 12 (0.8) 
 Any related 36 (4.5) 70 (4.4) 
 Any SAE 7 (0.9) 15 (0.9) 
 Related SAE 
 Deaths 2 (0.1) 
 New onset chronic disease 13 (1.6) 22 (1.4) 
 AE leading to study withdrawal 3 (0.2) 
 Medically attended AE 97 (12.0) 222 (13.9) 

AE, adverse event; QIV, US-licensed quadrivalent inactivated influenza vaccine; QIVc, cell-derived quadrivalent inactivated influenza vaccine; SAE, serious adverse event.

a

Data are descriptive in nature and no formal statistical comparisons were done.

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