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Trial registered on ANZCTR


Registration number
ACTRN12607000197437
Ethics application status
Approved
Date submitted
20/03/2007
Date registered
10/04/2007
Date last updated
10/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 285617 0
Nil
Universal Trial Number (UTN)
Trial acronym
Ischaemic Influenza Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of recurrent ischaemic vascular events 1719 0
Condition category
Condition code
Stroke 1811 1811 0 0
Ischaemic
Cardiovascular 1812 1812 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1660 0
Prevention
Comparator / control treatment
Control group: Controls will received a single dose of placebo vaccine by the intramuscular route. During the pilot phase, the control arm will not recieve a placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2533 0
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.
Timepoint [1] 2533 0
Actively monitored once a month for 12 mnths
Secondary outcome [1] 4379 0
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.
Timepoint [1] 4379 0
12 months
Secondary outcome [2] 4380 0
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.
Timepoint [2] 4380 0
12 months

Eligibility
Key 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).
Minimum age
40 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
During the pilot phase of the study (one year) no placebo will be used. During the full study, a placebo will be used, therefore both the subject, the administrator, the assessor and the data analyst will be blinded to who is randomised to each arm
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/04/2007
Actual
27/04/2007
Date of last participant enrolment
Anticipated
Actual
31/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3129 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 1962 0
Commercial sector/Industry
Name [1] 1962 0
GlaxoSmithKline
Country [1] 1962 0
Australia
Funding source category [2] 1963 0
Government body
Name [2] 1963 0
National Health and Medical Research Council
Country [2] 1963 0
Australia
Funding source category [3] 1964 0
Government body
Name [3] 1964 0
Australian Research Council
Country [3] 1964 0
Australia
Primary sponsor type
Government body
Name
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Address
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St,
Westmead NSW 2145, Australia
Country
Australia
Secondary sponsor category [1] 1773 0
Individual
Name [1] 1773 0
Dr Pramesh Kovoor
Address [1] 1773 0
Department of Cardiology Westmead Hospital
Cnr Darcy Rd & Bridge St,
Westmead NSW 2145
Country [1] 1773 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3658 0
Western Sydney Local Health District
Ethics committee address [1] 3658 0
Westmead Hospital
Rm 2020
Clinical Sciences Building
Westmead
New South Wales 2145
Ethics committee country [1] 3658 0
Australia
Date submitted for ethics approval [1] 3658 0
Approval date [1] 3658 0
27/03/2007
Ethics approval number [1] 3658 0
JH/TG HREC2007/2/4.8 (2533)

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27763 0
Prof Raina MacIntyre
Address 27763 0
School of Public Health and Community Medicine
University of New South Wales
Level 3, Samuels Building
Gate 11, Botany St, Randwick, 2031
Australia
Country 27763 0
Australia
Phone 27763 0
+61 02 9385 3811
Fax 27763 0
+61 2 9313 6185
Email 27763 0
[email protected]
Contact person for public queries
Name 10849 0
Holly Seale
Address 10849 0
School of Public Health and Community Medicine
University of New South Wales
Level 2, Samuels Building
Gate 11, Botany St, Randwick, 2031
Australia
Country 10849 0
Australia
Phone 10849 0
+61 02 9385 3129
Fax 10849 0
+61 02 9313 6185
Email 10849 0
[email protected]
Contact person for scientific queries
Name 1777 0
Professor Raina MacIntyre
Address 1777 0
School of Public Health and Community Medicine
University of New South Wales
Level 3, Samuels Building
Gate 11, Botany St, Randwick, 2031
Australia
Country 1777 0
Australia
Phone 1777 0
+61 02 9385 3811
Fax 1777 0
+61 02 9313 6185
Email 1777 0
[email protected]

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