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 2. Reactogenicity of moderate or greater severity for PCV7 according to age at dose administration: randomized trials in healthy children under 2 years of age
| Reactogenicitya | Age at dose administration (months) | Study |
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|---|---|---|---|---|---|---|---|---|
| Black et al. |
Eskola et al. |
Knuf et al. |
Scheifele et al. |
Schmitt et al. |
Tichmann-Schumann et al. |
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| PCV7 (n) | – | 693 | 831 | 125 | 376 | 118 | 175 | |
| Comparison | – | Men C | Hep B | Hexa | No PCV | Other vaccines | Other vaccines | |
| Redness (%) | 2 | 0.3 | 0 | 0.8 | 1.2 | 0 (3 months) | – | |
| 4 | 0 | 0.2 | 3.3 | 1.6 | 1.9 | – | ||
| 6 | 0.2 | 0.4 | 3.4 | 1.6 | 0 (5 months) | – | ||
| 12–15 | 0.6 | 0.9 | 7.3 | 4.4 | – | |||
| Swelling (%) | 2 | 0.1 | 1.1 | 2.5 | 4.8 | 0 (3 months) | – | |
| 4 | 0.4 | 1.0 | 5.0 | 1.2 | 1.0 | – | ||
| 6 | 0.5 | 0.5 | 5.2 | 3.2 | 0 (5 months) | – | ||
| 12–15 | 0.6 | 1.3 | 8.1 | – | 2.2 | – | ||
| Fever (%) | 2 | 0.9 | 0.4 | 0.8 | – | 3.8 (3 months) | 4.6 | |
| 4 | 2.5b | 1.0 | 0.8 | – | 2.9 | 4.1 (3 months) | ||
| 6 | 1.7 | 2.0b | 1.7 | – | 4.7 (5 months) | 2.4 (4 months) | ||
| 12–15 | 1.3 | 1.6 | 2.7 | – | 8.3 | 11.2 | ||
Hep B, hepatitis B; Hexa, INFANRIX® hexa; Men C, meningitis C; PCV7, 7-valent pneumococcal polysaccharide-protein conjugate vaccine.a Local reactions > 2.0 cm, > 2.4 cm or > 3.0 cm according to study; fever > 39 ºC.b Significantly (P < 0.05) higher with PCV7 than comparison vaccination.