Table 1. Unsolicited symptoms reported by at least 5% of subjects in either group, and unsolicited symptoms for which a statistically significant difference between groups was observed, within 31 d after each dose over the four-dose vaccination series (total vaccinated cohort, studies A/B only).

	HibMenCY n = 3136	Hib n = 1044	Relative Risk
Symptom	n (%)	n (%)	[95% CI]	p value
At least one symptom	2033 (64.8)	669 (64.1)	1.01 [0.93; 1.11]	0.82
Upper respiratory tract infection	635 (20.2)	209 (20.0)	1.01 [0.86; 1.19]	0.92
Otitis media	433 (13.8)	140 (13.4)	1.03 [0.85; 1.25]	0.81
Pyrexia	325 (10.4)	124 (11.9)	0.87 [0.71; 1.08]	0.22
Diarrhea	256 (8.2)	84 (8.0)	1.01 [0.79; 1.31]	0.97
Vomiting	252 (8.0)	93 (8.9)	0.90 [0.71; 1.16]	0.43
Teething	248 (7.9)	87 (8.3)	0.95 [0.74; 1.23]	0.72
Rash	203 (6.5)	72 (6.9)	0.94 [0.71; 1.25]	0.69
Cough	208 (6.6)	69 (6.6)	1.00 [0.76; 1.34]	1.00
Irritability	196 (6.3)	59 (5.7)	1.11 [0.82; 1.51]	0.55
Rhinorrhoea	189 (6.0)	63 (6.0)	1.00 [0.75; 1.35]	1.00
Nasal congestion	162 (5.2)	60 (5.7)	0.90 [0.66; 1.23]	0.52
Constipation	102 (3.3)	21 (2.0)	1.62 [1.00; 2.72]	0.05*
Insomnia	23 (0.7)	16 (1.5)	0.48 [0.24; 0.97]	0.04
Allergic rhinitis	17 (0.5)	13 (1.2)	0.44 [0.20; 0.97]	0.04
Croup	31 (1.0)	21 (2.0)	0.49 [0.27; 0.90]	0.02
Crying	6 (0.2)	7 (0.7)	0.29 [0.08; 0.99]	0.05*

N, total number of subjects in A/B only, with at least one administered dose; n (%), number (percentage) of subjects reporting the symptoms at least once. There were two preferred terms with p values for the Breslow and Day test that were significant, indicating a difference in relative reporting patterns between the different countries: application site hematoma (reported by 0.1% in the HibMenCY group and 0.3% in the Hib group, p = 0.03) and cough (p = 0.01), p values < 0.05 are highlighted in bold. *p < 0.05.