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Randomized Controlled Trial
. 2010 Mar 8:340:c1004.
doi: 10.1136/bmj.c1004.

Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial

Takaya Maruyama  1 , Osamu Taguchi, Michael S Niederman, John Morser, Hiroyasu Kobayashi, Tetsu Kobayashi, Corina D'Alessandro-Gabazza, Sei Nakayama, Kimiaki Nishikubo, Takashi Noguchi, Yoshiyuki Takei, Esteban C Gabazza
Affiliations
Randomized Controlled Trial

Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial

Takaya Maruyama et al. BMJ. .

Abstract

Objective: To determine the efficacy of a 23-valent pneumococcal polysaccharide vaccine in people at high risk of pneumococcal pneumonia.

Design: Prospective, randomised, placebo controlled double blind study.

Setting: Nursing homes in Japan.

Participants: 1006 nursing home residents.

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

Main outcome measures: 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.

Conclusion: 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.

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Conflict of interest statement

Competing interests: None declared.

Figures

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Fig 1 Flow diagram of trial
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Fig 2 Kaplan-Meier survival curves of participants without pneumococcal pneumonia in vaccine and placebo groups
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Fig 3 Kaplan-Meier survival curves of participants without all cause pneumonia in vaccine and placebo groups
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Fig 4 Kaplan-Meier survival curves of participants with different comorbidities, including pneumonia, in vaccine and placebo groups
See this image and copyright information in PMC

Comment in

References

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