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Table 1 Randomised studies of pneumococcal vaccination

From: Are the pneumococcal polysaccharide vaccines effective? Meta-analysis of the prospective trials

  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 bacteraemia2: Radiological pneumonia 1: Not given2: X-ray 84/1493358/3007 17/1493160/3007 10/1493113/3007     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/placeboabout 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/placebo16 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 36/271348/2660 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/placebo3 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 94/60799/693    75/60780/693 28/60738/693 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/placebo30 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   99/6782123/6818   749/6782723/6818 44/678246/6818   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 control2 years 1: Pneumonia 2: Pneumococcal pneumonia 3: Mortality 1: Definitions of pneumonia varied 7/93727/749 3/9379/749    1/9376/749   Study undertaken in 50 hospitals and homes in one district R1 DB0 W1
Klastersky et al, 1986 Patients with bronchogenic carcinoma 50 17 valent/placeboUp 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   2/264/21 1/261/21   1/261/21 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   19/114515/1150   22/114512/1150 28/114520/1150   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      2/504/53    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    1/920/97     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 69/136464/1473 26/136433/1473    5/13646/1473    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 63/33957/352 19/33916/352 1/3395/352   2/3393/352 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 40/66721/656 20/66714/656       R1 DB2 W1
  1. Quality scores are R = randomised, DB = double-blinding, W = Withdrawals (Jadad et al, 1996)