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Research Paper

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine when administered to healthy Japanese adults aged ≥50 years

An open-label trial

, , , , , , , , & show all
Pages 1850-1858 | Received 05 Nov 2013, Accepted 24 Mar 2014, Published online: 28 Apr 2014

Figures & data

Table 1. Pneumococcal OPA GMTs and subjects achieving OPA titers ≥ LLOQ by age group in the Japanese study (evaluable immunogenicity population)

Table 2. Serotype pneumococcal OPA GMTs for age groups 50–64 y and ≥65 y across studies (evaluable immunogenicity population)

Figure 1. Scatter plots and regression analysis between prevaccination diphtheria toxoid IgG concentrations and postvaccination pneumococcal OPA titers by serotype and age group (evaluable immunogenicity population). IgG, immunoglobulin G; OPA, opsonophagocytic activity.

Figure 1. Scatter plots and regression analysis between prevaccination diphtheria toxoid IgG concentrations and postvaccination pneumococcal OPA titers by serotype and age group (evaluable immunogenicity population). IgG, immunoglobulin G; OPA, opsonophagocytic activity.

Figure 2. Subjects reporting local reactions within 14 d after vaccination by age group (safety population)*. *Severity of local reactions were categorized as follows: redness and swelling, mild = 2.5–5.0 cm, moderate = 5.1–10.0 cm, and severe >10.0 cm; pain, mild = awareness of symptom but easily tolerated, moderate = discomfort enough to cause interference with usual activity, and severe = incapacitating with inability to do usual activity; limitation of arm movement, mild = some limitation, moderate = unable to move above head but able to move above shoulder, and severe = unable to move above shoulder. Abbreviation: EU, European Union.

Figure 2. Subjects reporting local reactions within 14 d after vaccination by age group (safety population)*. *Severity of local reactions were categorized as follows: redness and swelling, mild = 2.5–5.0 cm, moderate = 5.1–10.0 cm, and severe >10.0 cm; pain, mild = awareness of symptom but easily tolerated, moderate = discomfort enough to cause interference with usual activity, and severe = incapacitating with inability to do usual activity; limitation of arm movement, mild = some limitation, moderate = unable to move above head but able to move above shoulder, and severe = unable to move above shoulder. Abbreviation: EU, European Union.

Table 3. Subjects reporting systemic events within 14 d after vaccination by age group (safety population)

Supplemental material

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