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
- Conditions
- Prevention of recurrent ischaemic vascular eventsStroke - IschaemicCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12607000197437
- Lead Sponsor
- ational Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- Male
- Target Recruitment
- 500
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To quantify the impact of influenza vaccination on the incidence of recurrent ischaemic events in high risk patients aged 40-64 years, Intention to treat analysis will be used, comparing the rate of study endpoints in the vaccine and placebo groups. The arms will be compared to clinical and sociodemographic characteristics to ensure there is no bias in the sample. [Actively monitored once a month for 12 mnths]
- Secondary Outcome Measures
Name Time Method The extent of undiagnosed influenza in patients aged 40-64 years admitted to hospital, and its contribution to precipitation of acute ischaemic events are quantified as follows: subjects will be followed for a period of 12 months following enrolment, with monthly phone calls. They will also be asked to record on a diary card, whether any endpoints occur. The endpoints include influenza like illness, heart attack, stroke or mini stroke.[12 months];If an influenza like illness is reported, follow up serology will be obtained, and if the patient is still symptomatic, a nasal and throat swab will be taken for influenza. If death, ischaemic events or hospitalisation occur, the study team will review hospital medical records and liaise with the relevant general practitioner to obtain detailed information. Validation will be sought from hospital or GP medical records.[12 months]