Condition category
Respiratory
Date applied
17/11/2014
Date assigned
17/11/2014
Last edited
01/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Globally, it is estimated that seasonal influenza is responsible for five million cases of severe illness and 500,000 deaths per year, in particular older adults aged 65 and over and people with underlying diseases such as asthma. National influenza vaccination strategies using primary care represent a potentially important approach to reduce both influenza-related illness and death, hence the considerable investment in this preventive approach in many parts of the world. In Scotland new policy interventions are imminent and will result in the broader coverage of the vaccine, e.g. a new type of influenza vaccine (live attenuated influenza vaccine) is being introduced this year to all children (between 2 and 17 years). However, the evaluation of changes to immunisation programmes can be problematic given that randomised controlled trials of the vaccine are impractical and also viewed as unethical by some sections of the medical community. These policy changes therefore typically go unevaluated, making it difficult to inform ongoing policy deliberations. Building on our substantial track-record of evaluating vaccine programmes using linked healthcare electronic record-derived information, we will conduct an evaluation of the live attenuated influenza vaccine.

Who can participate?
Rather than recruiting participants, the SIVE II project instead uses data collected from routinely available datasets.

What does the study involve?
Rather than recruiting participants, the SIVE II project instead uses data collected from routinely available datasets.

What are the possible benefits and risks of participating?
The observational study design being used to assess the effectiveness of influenza vaccine does not influence the care that is provided or the people who receive it. Therefore there are minimal risks and no direct benefits to patients.

Where is the study run from?
Centre for Population Health Sciences (UK).

When is the study starting and how long is it expected to run for?
The study will run from October 2014 to April 2017.

Who is funding the study?
NIHR Health Technology Assessment - HTA (UK).

Who is the main contact?
Dr Colin Simpson
c.simpson@ed.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colin Simpson

ORCID ID

http://orcid.org/0000-0002-5194-8083

Contact details

Centre for Population Health Sciences
Medical School
Teviot
Edinburgh
EH8 9AG
United Kingdom
+44 131 651 4151
c.simpson@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/34/14

Study information

Scientific title

Seasonal Influenza Vaccination Effectiveness II (SIVE II): use of a large national primary care and laboratory-linked dataset to evaluate live attenuated and trivalent inactivated influenza vaccination effectiveness

Acronym

SIVE II

Study hypothesis

To provide early estimates of the uptake and effectiveness of LAIV administered to children (from 2013) and explore indirect effects of LAIV on the general population. Our secondary aim is to evaluate the effectiveness of seasonal TIV amongst older people (65 years and older) and those with asthma under 65.

Ethics approval

NRES Committee West Midlands - Edgbaston, 22/01/2015, ref: 15/WM/0035

Study design

Observational longitudinal cohort study with nested-case control study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Influenza

Intervention

16 influenza vaccine programmes implemented in Scotland will be evaluated for effectiveness.

Intervention type

Biological/Vaccine

Phase

Not Applicable

Drug names

Primary outcome measures

Influenza positivity from virological swab data in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socioeconomic status

Secondary outcome measures

1. Consultation for influenza-related morbidity (e.g., influenza, pneumonia, chronic obstructive pulmonary disease [COPD] and cardiac-related consultations) and issue of antiviral therapy from general practice data in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socio-economic status
2. Mortality and influenza-related serious morbidity (e.g., influenza, pneumonia, COPD and cardiac-related death and hospitalisation from SMR01 records) in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socioeconomic status

Overall trial start date

01/10/2014

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

All (anonymised) patient data will be collected

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

2,000,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2014

Recruitment end date

01/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Population Health Sciences
Edinburgh
EH8 9AG
United Kingdom

Sponsor information

Organisation

Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)

Sponsor details

c/o Raymond French
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 131 242 9471
ray.french@ed.ac.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (HTA 13/34/14)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/04/2016: The availability of the participant level data has been updated, along with the publication and dissemination plan. 24/03/2016: Ethics approval information added.