Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.

The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.

Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.

Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.

The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.

Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.

A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels < 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.

Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.

Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).

Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.

Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).

Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.

Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.

The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F.

Evaluable per protocol population for pneumococcal polysaccharide vaccine. N indicates the number of participants with available data for each serotype. No imputation was performed.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.

All participants who received at least one dose of study treatment were included in the safety evaluation.