None listed
Conditions
Brief 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.
Interventions
pneumococcal polysaccharide vaccine 0.25mcg(0.5mls) standard dose given intramuscularly at baseline recruitment only
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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).
Outcome results
None listed