Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial.
OBJECTIVE
To determine the efficacy of a 23-valent pneumococcal polysaccharide vaccine in people at high risk of pneumococcal pneumonia.


METHODS
Prospective, randomised, placebo controlled double blind study.


METHODS
Nursing homes in Japan.


METHODS
1006 nursing home residents.


METHODS
Participants were randomly allocated to either 23-valent pneumococcal polysaccharide vaccine (n=502) or placebo (n=504).


METHODS
The primary end points were the incidence of all cause pneumonia and pneumococcal pneumonia. Secondary end points were deaths from pneumococcal pneumonia, all cause pneumonia, and other causes.


RESULTS
Pneumonia occurred in 63 (12.5%) participants in the vaccine group and 104 (20.6%) in the placebo group. Pneumococcal pneumonia was diagnosed in 14 (2.8%) participants in the vaccine group and 37 (7.3%) in the placebo group (P<0.001). All cause pneumonia and pneumococcal pneumonia were significantly more frequent in the placebo group than in the vaccine group: incidence per 1000 person years 55 v 91 (P<0.0006) and 12 v 32 (P<0.001), respectively. Death from pneumococcal pneumonia was significantly higher in the placebo group than in the vaccine group (35.1% (13/37) v 0% (0/14), P<0.01). The death rate from all cause pneumonia (vaccine group 20.6% (13/63) v placebo group 25.0% (26/104), P=0.5) and from other causes (vaccine group 17.7% (89/502) v placebo group (80/504) 15.9%, P=0.4) did not differ between the two study groups.


CONCLUSIONS
The 23-valent pneumococcal polysaccharide vaccine prevented pneumococcal pneumonia and reduced mortality from pneumococcal pneumonia in nursing home residents. Trial registration Japan Medical Association Center for Clinical Trials JMA-IIA00024.
Maruyama
Takaya
T
Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Tsu City, Mie Prefecture, Japan.
Taguchi
Osamu
O
Niederman
Michael S
MS
Morser
John
J
Kobayashi
Hiroyasu
H
Kobayashi
Tetsu
T
D'Alessandro-Gabazza
Corina
C
Nakayama
Sei
S
Nishikubo
Kimiaki
K
Noguchi
Takashi
T
Takei
Yoshiyuki
Y
Gabazza
Esteban C
EC
D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D006707:Homes for the Aged; D006801:Humans; D007326:Institutionalization / Q000706:statistics & numerical data; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009735:Nursing Homes; D022242:Pneumococcal Vaccines / Q000627:therapeutic use*; D011018:Pneumonia, Pneumococcal / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome
C414006:23-valent pneumococcal capsular polysaccharide vaccine; D022242:Pneumococcal Vaccines