Table 2

Incidence of overall per dose grade 3 solicited symptoms reported within 4 days post-vaccination and of grade 3 unsolicited symptoms reported within 31 days post-vaccination (total vaccinated cohort)
PHiD-CV group N=583/585* Control group N=297
Grade 3 Symptom n % [95% CI] n % [95% CI]
Any symptom 48 8.2 [6.1, 10.8] 9 3.0 [1.4, 5.7]
Local symptom 43 7.4 [5.4, 9.8] 6 2.0 [0.7, 4.3]
Pain 38 6.5 [4.7, 8.8] 3 1.0 [0.2, 2.9]
Redness 5 0.9 [0.3, 2.0] 1 0.3 [0.0, 1.9]
Swelling 7 1.2 [0.5, 2.5] 2 0.7 [0.1, 2.4]
General symptom 13 2.2 [1.2, 3.8] 3 1.0 [0.2, 2.9]
Drowsiness 3 0.5 [0.1, 1.5] 0 0.0 [0.0, 1.2]
Fever 0 0.0 [0.0, 0.6] 1 0.3 [0.0, 1.9]
Irritability 11 1.9 [0.9, 3.4] 1 0.3 [0.0, 1.9]
Loss of appetite 0 0.0 [0.0, 0.6] 0 0.0 [0.0, 1.2]
Unsolicited symptom 2 0.3 [0.0, 1.2] 1 0.3 [0.0, 1.9]

PHiD-CV group= infants vaccinated with PHiD-CV co-administered with DTPa-HBV-IPV/Hib at 2, 3, and 4 months of age; Control group= infants vaccinated with DTPa-HBV-IPV/Hib at 2, 3, and 4 months of age; N= number of doses; *= number of administered doses for unsolicited symptom; n= number of reported symptoms; %= percentage of doses followed by the specified symptom with grade 3 intensity; 95% CI= 95% confidence interval.

Huu et al.

Huu et al. BMC Infectious Diseases 2013 13:95   doi:10.1186/1471-2334-13-95

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