A randomised, controlled clinical trial of influenza vaccine in the prevention of recurrent ischaemic vascular events in patients with recent myocardial infarction, a transient ischaemic attack or with an ischaemic cerebrovascular event (stroke), aged between 40-64 years of age

A randomised, controlled clinical trial of influenza vaccine in the prevention of recurrent ischaemic vascular events in adult patients with recent myocardial infarction, a transient ischaemic attack or with an ischaemic cerebrovascular event (stroke), aged 40-64 years

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000197437

Acronym

Ischaemic Influenza Study

Enrollment

500

Registered

2007-04-10

Start date

2007-04-27

Completion date

2007-07-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Influenza is a cause of significant morbidity and mortality, particularly in the elderly during the annual winter epidemics. There is indirect epidemiologic evidence that influenza also contributes to all-cause mortality and to cardiac, stroke and respiratory hospitalisations. Cardiovascular and cerebrovascular diseases are the single largest contributor to disease burden in Australia, accounting for 18% of the total disability-adjusted life years lost. Given the observational data which suggest that influenza is a precipitant for ischaemic events, prevention of influenza by vaccination may have an important role in reducing the burden of ischaemic events. Our study aims to quantify the impact of influenza vaccination on the incidence of ischaemic events in high risk patients aged 40-64 years

Interventions

Intervention group: Patients in the intervention arm will receive a single dose of inactivated influenza virus vaccine by the intramuscular route. The antigen composition and strains used for the 2007 pilot study will be A/New Caledonia/20/99 (H1N1)- 15ug haemagglutinin per dose A/Wisconsin/67/2005 (H3N2)-15ug haemagglutinin per dose B/Malaysia/2506/2004- 15ug haemagglutinin per dose

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

40 Years to 64 Years

Healthy volunteers

Inclusion criteria

Must not have received influenza vaccine in the study year.Consent must be givenHas to be admitted to hospital with either an Acute, evolving or recent myocardial infarction, or a Transient ischaemic attack or with a Ischaemic cerebrovascular event (stroke).

Exclusion criteria

Inability or refusal to consent.Already vaccinated against influenza during the study year Has a medical contraindication to vaccination (egg allergy) or gentamicin Is outside of the specified age groupHas had a Haemorrhagic stroke or chronic cardiac disease including congestive cardiac failure.Guillain-Barre Syndrome.

Outcome results