Table 1.
Baseline characteristics of 1006 Japanese nursing home residents at randomisation to 23-valent pneumococcal polysaccharide vaccine or placebo (sodium chloride). Values are numbers (percentages) unless stated otherwise
| Characteristics | Vaccine group (n=502) | Placebo group (n=504) |
|---|---|---|
| Mean (SD) age (years); range | 84.7 (7.7); 55-102 | 84.8 (7.6); 56-105 |
| Age group: | ||
| 55-64 | 9 (1.8) | 11 (2.2) |
| 65-74 | 42 (8.4) | 35 (6.9) |
| 75-84 | 168 (33.5) | 182 (36.1) |
| 85-94 | 236 (47.0) | 244 (48.4) |
| 95-105 | 47 (9.4) | 32 (6.3) |
| Men | 111 (22.1) | 109 (21.6) |
| Mean (SD) ECOG (performance status score*) | 2.2 (0.9) | 2.2 (0.9) |
| Mean (SD) body weight (kg) | 43.8 (8.7) | 43.8 (9.4) |
| Mean (SD) height (cm) | 153.3 (6.8) | 153.8 (7.1) |
| Mean (SD) body mass index | 19.8 (3.7) | 19.8 (3.6) |
| Vaccinated against influenza | 500 (99.6) | 500 (99.2) |
| Risk factors and comorbid conditions: | ||
| Smoker | 31 (6.2) | 29 (5.8) |
| Consumes alcohol† | 25 (5.0) | 21 (4.2) |
| Bedridden | 58 (11.6) | 50 (9.9) |
| Cerebrovascular disease | 177 (35.3) | 172 (34.1) |
| Chronic pulmonary disease‡ | 36 (7.2) | 34 (6.7) |
| Malignancy | 11 (2.2) | 8 (1.6) |
| Psychological disorder | 29 (5.8) | 20 (4.0) |
| Diabetes mellitus | 50 (10.0) | 54 (9.9) |
| Congestive heart failure | 34 (6.8) | 34 (6.7) |
| Other heart disease | 43 (8.6) | 44 (8.7) |
| Chronic liver disease | 13 (2.6) | 11 (2.2) |
| Chronic renal disease | 10 (2.0) | 15 (3.0) |
| Gastrostomy | 7 (1.4) | 8 (1.6) |
| Gastrectomy | 1 (0.2) | 4 (0.8) |
| Post-surgical | 10 (2.0) | 8 (1.6) |
| Bone fracture | 3 (0.6) | 4 (0.8) |
| Hypertension | 101 (20.1) | 114 (22.6) |
| Hyperlipidaemia | 10 (2.0) | 16 (3.2) |
| Other | 29 (5.8) | 40 (7.9) |
| No of comorbid conditions: | ||
| None | 151 (30.1) | 142 (28.2) |
| 1 | 197 (39.2) | 209 (41.5) |
| 2 | 109 (21.7) | 106 (21.0) |
| ≥3 | 45 (9.0) | 47 (9.3) |
| Mean (SD) white blood cell count (×109/l) | 5.92 (1.76) | 5.87 (1.61) |
| Mean (SD) haemoglobin (g/l) | 118 (16) | 118 (16) |
| Mean (SD) haematocrit (%) | 36.5 (4.6) | 36.6 (4.8) |
| Mean (SD) total protein (g/l) | 66.8 (6.1) | 67.2 (5.4) |
| Mean (SD) albumin (g/l) | 37.3 (4.1) | 37.6 (4.0) |
| Mean (SD) IgG (g/l) | 15.88 (3.96) | 16.24 (3.90) |
| Mean (SD) total cholesterol (mmol/l) | 4.75 (1.03) | 4.78 (1.03) |
| Mean (SD) cholinesterase (IU/l) | 824.5 (163.3) | 853.8 (190.9) |
| Mean (SD) creatine kinase (U/l) | 69.0 (44.0) | 72.6 (60.2) |
| Mean (SD) blood urea nitrogen (g/l) | 6.78 (3.28) | 6.60 (2.78) |
| Mean (SD) creatinine (μmol/l) | 68.1 (37.1) | 67.2 (30.1) |
| Mean (SD) sodium (mmol/l) | 140.2 (3.9) | 140.6 (3.74) |
| Mean (SD) potassium (mmol/l) | 4.05 (0.56) | 4.07 (0.60) |
| Mean (SD) chloride (mmol/l) | 102.4 (4.4) | 102.7 (4.3) |
ECOG=Eastern Cooperative Oncology Group.
*From grade 0, fully active, able to carry on all pre-disease performance without restriction to grade 5, death.
†<15 g/day.
‡Includes patients with emphysema, bronchiectasis, and old pulmonary tuberculosis.