Bulletin of the World Health Organization

Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data

Frank DeStefano, Dina Pfeifer, Hanna Nohynek

Volume 86, Number 5, May 2008, 373-380

Table 1. Reactogenicity of any severity for PCV7 according to age at dose administration: randomized trials in healthy children under 2 years of age

Reactogenicity	Age at dose administration (months)	Study
Reactogenicity	Age at dose administration (months)	Black et al.⁵	Choo et al.⁹	Eskola et al.⁶	Knuf et al.¹²	Rennels et al.¹⁰	Scheifele et al.¹³	Schmitt et al.¹⁴	Shinefield et al.¹¹	Tichmann-Schumann et al.¹⁵
PCV7 (n)	–	693	368	831	125	106	376	118	272	175

Comparison	–	Men C	No PCV	Hep B	Hexa	Other vaccines	No PCV	Other vaccines	DTP-Hib	Other vaccines

Redness (%)	2	10.0	–	14^a	21.8	–	19.4	14.2(3 months)	17.0	39.3
	4	11.6^a	–	16	29.2	–	23.6	16.0	18.0^b	42.4(3 months)
	6	13.8^a	–	20^a	23.9	–	36.7	20.8(5 months)	16.0	37.1(4 months)
	12–15	10.9	–	15	32.1	–	–	31.9	9.1	51.4

Swelling (%)	2	9.8^a	–	6^a	24.4	–	27.0	6.6(3 months)	10.0^b	22.5^a
	4	12	–	5	28.6	–	25.6	9.5	11.0^b	29.1(3 months)
	6	10.4^a	–	5	21.3	–	27.7	0.8(5 months)	9.0^b	26.5(4 months)
	12–15	12.1	–	6	36.9	–	–	9.9	6.4	37.0

Fever (%)	2	15.1^a	2–4	14.3^a	32.8	25	–	44.5(3 months)	21.5	42.8^a
	4	23.9^a	2(3 months)	18.4^a	42.3	28	–	33.0	33.5	49.4^a(3 months)
	6	19.1^a	1–6(4 months)	23.5^a	28.3	38	–	29.0(5 months)	29.6	33.5^a(4 months)
	12–15	21	–	11.5^a	50.0	22	–	48.2	11.0	48.6

DTP-Hib, diphtheria, pertussis, tetanus, and Haemophilus influenzae type b; Hep B, hepatitis B; Hexa, INFANRIX® hexa; Men C, meningitis C; PCV7, 7-valent pneumococcal polysaccharide-protein conjugate vaccine.^a Significantly (P < 0.05) higher with PCV7 than comparison vaccination.^b Significantly (P < 0.05) lower with PCV7 than comparison vaccination.