SIVE II: an evaluation of the seasonal influenza vaccine using routine data sources

ISRCTN	ISRCTN88072400
DOI	https://doi.org/10.1186/ISRCTN88072400
Secondary identifying numbers	HTA 13/34/14

Submission date: 17/11/2014
Registration date: 17/11/2014
Last edited: 12/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Contact information

Dr Colin Simpson
Scientific

Centre for Population Health Sciences
Medical School
Teviot
Edinburgh
EH8 9AG
United Kingdom

ORCID ID	0000-0002-5194-8083
Phone	+44 131 651 4151
Email	c.simpson@ed.ac.uk

Study information

Study design	Observational longitudinal cohort study with nested-case control study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study 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(s)	NRES Committee West Midlands - Edgbaston, 22/01/2015, ref: 15/WM/0035
Condition	Influenza
Intervention	16 influenza vaccine programmes implemented in Scotland will be evaluated for effectiveness.
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/10/2014
Overall study end date	01/04/2017

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	2,000,000
Total final enrolment	1250000
Participant inclusion criteria	All (anonymised) patient data will be collected
Participant exclusion criteria	Does not meet inclusion criteria
Recruitment start date	01/10/2014
Recruitment end date	01/04/2017

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Centre for Population Health Sciences

Edinburgh
EH8 9AG
United Kingdom

Sponsor information

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

c/o Raymond French
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Phone	+44 131 242 9471
Email	ray.french@ed.ac.uk
"ROR"	https://ror.org/01x6s1m65

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication of study results in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/02/2017	23/10/2020	Yes	No
Results article	results	01/12/2020	12/03/2021	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

12/03/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
23/10/2020: Publication reference added.
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.