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

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

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)

Moore et al. BMC Family Practice 2000 1:1 doi:10.1186/1471-2296-1-1