Study Support Service - Early Feedback Service

Study name: PASS flu vaccine study
Type: Commercial
Funder: Seqirus PTY Ltd
Number of sites: 10
Recruitment target: 250
Recruitment achieved: 273

Seasonal flu vaccines are essential to the prevention of fl u worldwide. Over the last two years the NIHR Clinical Research Network has successfully supported studies in the UK for Seqirus – one of the world’s leading flu vaccine providers.

Dr David Bibby, Clinical Operations and vaccine specialist at Seqirus, tells us more:

“Influenza vaccines are unique because the virus constantly mutates. The World Health Organisation and other monitoring bodies determine which strains go into the vaccines for the northern and southern hemisphere winters. That happens twice a year, the strains are announced in September or February depending on which hemisphere you’re in. So generally speaking, the product changes annually.”

The purpose of this post-authorisation safety study, or PASS, was to evaluate the safety and benefit-risk profile of the influenza vaccine and support regulatory decision-making.

“It’s a great option to have the ability to request early feedback on a proposal from selected NIHR lead investigators. Whether it’s ‘you’re on the right track, have you thought about X or Y?’ We’re getting expert feedback from key opinion leaders..."

The Network has supported PASS for Seqirus’ seasonal infl uenza vaccine in both 2014 and 2015. So what was the benefit of working with the Clinical Research Network for Seqirus? Dr Bibby explains:

“The NIHR offers a smooth process of submission, and access to a large number of primary care sites and healthcare professionals across the UK. It was our ability to utilise the NIHR’s extensive primary care network that made the UK a viable option for placing the studies.

“The NIHR acts as a central point with which to gauge an indication interest from potential participants, in the defi ned timelines, across a huge number of sites. We know you will return with a response to the survey questions we have posed within the agreed timeline – it’s really the certainty that that brings, through the central portal, that was real plus.”

He adds:

“It’s a great option to have the ability to request early feedback on a proposal from selected NIHR lead investigators. Whether it’s ‘you’re on the right track, have you thought about X or Y?’ We’re getting expert feedback from key opinion leaders within the Network. The NIHR website offers a simple submission process for surveying a large number of primary care sites across the UK – and that’s the real key. The fact that it’s an up-to-date network, that the contacts are there, that they are brought into one
central point – we can then work with the Network to establish contact with them.”

Dr Bibby tells us what the PASS studies involve for participants:

“They are very light touch observational studies. All the participants were coming into their GP surgery or healthcare centre for their annual fl u shot anyway. They were asked if they were interested in taking part in some research on the vaccine they were about to receive. If they agreed the participants provided their email address, were given some information to take home with them, and later contacted by the investigator.”

“The participants received a link to the web portal and were asked to enter in a few registration details and answer a brief series of questions over the next seven days.

“By doing it all online we were able to get a near real-time lead on how the drug is being tolerated – effectively consent was obtained on the same day.”

The benefits of working with the Network for major pharma companies such as Seqirus seem clear. Dr Bibby concludes:

“The Clinical Research Network’s there to improve collaboration between industry and UK science – it’s kudos to the team that you do exactly that. In addition you’re just a friendly bunch of people to work with.”