Table 1.
Randomised studies of pneumococcal vaccination
| Number affected/total | |||||||||||||
| Reference | Patient population | Number of patients | Vaccine type/Follow up | Diagnostic endpoints | Diagnostic criteria | All cause pneumonia | Pneumocccal pneumonia | Pneumococcal bacteraemia | LRTI | Pneumonia death | Adverse effects | Comments | Quality |
| Austrian, 1976 | South African novice gold mine workers | 4500 | 15 valent/placebo 2 years | 1: Putative pneumococcal pneumonia and/or bacteraemia 2: Radiological pneumonia | 1: Not given 2: X-ray | 84/1493 358/3007 | 17/1493 160/3007 | 10/1493 113/3007 | Meningococcal vaccine and placebo combined. Methods not presented. | R2 DB0 W0 | |||
| Smit et al, 1977 | South African novice gold mine workers | 4694 | 6 or 12 valent/placebo about 2 years | 1: Pneumonia 2: Bronchitis 3: Pneumococcal pneumonia | 1: 3 or more symptoms ± X-ray confirmation for pneumonia 2: Bronchitis not specifically defined ± X-ray 3: Culture | 55/1523 169/3171 | 10/1523 103/3171 | 97/1523 238/3171 | No clinically important reactions | Pneumonia occurring more than 14 days after vaccination. | R1 DB0 W0 | ||
| Riley et al, 1977 | Papua New Guinea highlanders | 11958 | 14 valent/placebo 16 months | 1: Pneumonia 2: LRTI 3: Respiratory death | 1: Clinical ± X-ray 2: Sick, cough, pulmonary involvement 3: Questioning of relatives for symptoms of pneumonia | 36/2713 48/2660 | 2/2713 14/2660 | 78/2713 90/2660 | 68/5946 94/6012 | 3% with swollen arm 24% sore arm 7% fever in 131 patients | LRTI do not include pneumonia | R1 DB2 W0 | |
| Austrian, 1980 [1] | Institutionalised mentally ill patients | 1300 | 12 valent/placebo 3 years | 1: Respiratory illness 2: Clinical pneumonia 3: Radiological pneumonia 4: Pneumococcal pneumonia | 1: Clinically diagnosed 2: Clinically diagnosed 3: X-ray positive 4: X-ray positive seropositive pneumonia | 94/607 99/693 | 75/607 80/693 | 28/607 38/693 | Erythema 213/607 12/693 Induration 79/607 4/693 | LRTI do not include pneumonia | R1 DB2 W0 | ||
| Austrian, 1980 [2] | Ambulatory population > 45 years in a health plan | 13600 | 12 valent/placebo 30 months | 1: Respiratory illness 2: Clinical pneumonia 3: Radiological pneumonia 4: Pneumococcal pneumonia | 1: Clinically diagnosed 2: Clinically diagnosed 3: X-ray positive 4: X-ray positive seropositive pneumonia | 99/6782 123/6818 | 749/6782 723/6818 | 44/6782 46/6818 | Pneumococcal pneumonia here is more properly pneumococcal illness. LRTI includes pneumonia. Patients taken rather than number of ilnesses. | R2 DB0 W0 | |||
| Gaillat et al, 1985 | Persons >55 years living in residential homes and hospitals | 1686 | 14 valent/untreated control 2 years | 1: Pneumonia 2: Pneumococcal pneumonia 3: Mortality | 1: Definitions of pneumonia varied | 7/937 27/749 | 3/937 9/749 | 1/937 6/749 | Study undertaken in 50 hospitals and homes in one district | R1 DB0 W1 | |||
| Klastersky et al, 1986 | Patients with bronchogenic carcinoma | 50 | 17 valent/placebo Up to one year | 1: Pneumococcal infection 2: Pneumococcal bacteraemia 3: Pneumococcal death | 1: Febrile episodes with pneumococci + X-ray 2: as 1 plus blood culture | 2/26 4/21 | 1/26 1/21 | 1/26 1/21 | No adverse reactions noticed | Most patients receiving therapy likely to impair immunological responses. | R1 DB0 W1 | ||
| Simberkoff et al, 1986 | Persons >55 years and increased risk | 2295 | 14 valent/placebo mean 2.9 years | 1: Proved or probable pneumococcal pneumonia 2: Proved or probable pneumococcal bronchitis 3: Mortality | 1: Pneumococcal infection is clinical infection and positive culture 2: Pneumococcal pneumonia is clinical infection, X-ray and positive culture 3: Bronchitis clinical plus negative chest X-ray plus positive culture | 19/1145 15/1150 | 22/1145 12/1150 | 28/1145 20/1150 | LRTI is bronchitis. | R2 DB2 W1 | |||
| Davis et al, 1987 | Patients with chronic obstructive pulmonary disease | 103 | 14 valent/placebo up to 2 years | 1: Pneumonia 2: Deaths from pneumonia | 1: Clinical, X-ray and positive culture | 2/50 4/53 | R2 DB1 W1 | ||||||
| Leech et al, 1987 | Patients with chronic obstructive pulmonary disease | 189 | 14 valent plus influenza vaccine/influenza vaccine plus placebo 2 years | 1: LRTI 2: Pneumonia 3: Mortality | 1: Fever, cough, sputum characteristics 2: LRTI plus positive X-ray | 1/92 0/97 | Information by illness episodes not by patients experiencing illness. | R1 DB1 W1 | |||||
| Koivula et al, 1997 | People 60 years or older | 2837 | 14 valent plus influenza vaccine/influenza vaccine alone | 1: Pneumonia 2: Pneumococcal pneumonia 3: Pneumonia deaths | 1: X-ray 2: Serological positive | 69/1364 64/1473 | 26/1364 33/1473 | 5/1364 6/1473 | R2 DB0 W1 | ||||
| Örtqvist et al, 1998 | Non-immunocompromised patients aged 50 to 85 years with previous history of community acquired pneumonia | 691 | 23-valent/placebo 5 years | 1: Pneumonia 2: Pneumococcal pneumonia 3: Pneumonia deaths | 1: Clinical plus X-ray 2: Pneumonia plus culture or serology | 63/339 57/352 | 19/339 16/352 | 1/339 5/352 | 2/339 3/352 | No serious adverse events | R2 DB1 W1 | ||
| French et al, 2000 | HIV-1 infected Ugandans <55 years (about 14% with previous history of pneumonia) | 1323 | 23-valent/placebo 1 year | 1: Invasive pneumococcal disease 2: Pneumococcal pneumonia 3: All pneumonia | 1: All definite and probable invasive pneumococcal disease events | 40/667 21/656 | 20/667 14/656 | R1 DB2 W1 | |||||
Quality scores are R = randomised, DB = double-blinding, W = Withdrawals (Jadad et al, 1996)