Influenza Clinical Trial
Official title:
A Multi-centre, Phase II, Open Labelled Randomised Control Trial to Describe Immune & Transcriptomic Responses to Trivalent Inactivated Vaccine (TIV) & MF59 Adjuvanted Influenza Vaccine (ATIV) in 14 -26 Month Healthy Children
Infants and young children do not respond as well as adults to the flu vaccines currently
available in the UK. Fluad, is a different type of influenza vaccine that has been available
in the European continent for the last decade, and contains an adjuvant known as MF59.
This vaccine has been used extensively in adults over 65 years of age. It has been
administered to over 4000 children in previous studies, which have shown that it produces an
enhanced immune response in children compared with traditional vaccines, and that it is safe
in this age group. It is, however, not yet licensed for use in children. The reason for this
new study is to gain a better understanding of the how this vaccine is stimulating the immune
system, by looking to see which parts of the genetic code are 'switched on' in response to
immunisation, and to see how this differs from the response to currently used flu vaccines.
To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive
either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines
currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find
out whether it is possible to identify patterns of genetic response which can predict
responses to immunisation. Being able to do so could potentially enable more rapid
development of vaccines against influenza and other diseases in the future. We will also
measure how well the immune system responds to the two vaccines and look at any side effects.
The study is funded by Aditec is a collaborative research programme that aims to accelerate
the development of novel and powerful immunisation technologies for the next generation of
human vaccines.
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