Australian Study for the Prevention through Immunisation of Cardiovascular Events
Pneumococcal polysaccharide vaccine versus Normal Saline for primary prevention of heart attacks and strokes in at-risk Australians aged 55-60
University of Newcastle
4,500 participants
Feb 23, 2016
Interventional
Conditions
Summary
This is a multi-centre trial to investigate the effects of the pneumococcal vaccination in the primary prevention of heart attacks and strokes. People aged 55 to 60 from 6 sites around Australia will be invited to participate in the study. The selected participants will attend a clinic in their area and will be randomly given the pneumococcal vaccine or a placebo vaccine. Outcomes on the expected 6000 participants will be ascertained by health record linkage with government databases after 6 years.
Eligibility
Inclusion Criteria1
- Men and women aged 55-60 years with no known CVD events and two or more risk factors for CVD. Risk factors include hypercholesterolaemia, hypertension, elevated BMI, and elevated waist circumference.
Exclusion Criteria1
- Previous pneumococcal vaccination, previous cardiovascular events and any other condition for which the use of the vaccine is indicated (as per the Australian Immunisation Handbook).
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Interventions
pneumococcal polysaccharide vaccine 0.25mcg(0.5mls) standard dose given intramuscularly at baseline recruitment only
Locations(6)
View Full Details on ANZCTR
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ACTRN12615000536561