ADITEC Flu2
Research type
Research Study
Full title
A phase II, open label trial to describe immune and transcriptional responses to MF59 adjuvanted trivalent influenza vaccine (ATIV) in 13-24 month healthy children and adults 18-65 years
IRAS ID
179215
Contact name
Andrew Pollard
Contact email
Sponsor organisation
University of Oxford
Eudract number
2015-001648-12
Duration of Study in the UK
1 years, 6 months, 26 days
Research summary
This research study will be exploring the immune response of children aged 13 to 24 months to immunisation with an influenza vaccine, and how this response is initiated at a genetic level. We will also be comparing how these responses differ in children and healthy adults aged 18 -65 years.
Children under 2 years of age respond less well than older children to immunisation with the currently available flu vaccine used in the United Kingdom. In this study we will be exploring an alternative vaccine (adjuvanted trivalent influenza vaccine; ATIV) which has an adjuvant (something which helps stimulate the body’s immune response to immunisations) called MF59 . Previous clinical studies of this vaccine have enrolled over 4000 children and shown that it generates a better immune response than conventional influenza vaccines, without raising any safety concerns.
We know that when children’s immune systems respond to infections or vaccines, specific ‘immune response’ genes are activated, resulting in different types of immune responses. We aim to identify the specific ‘immune response’ genes which are activated (switched on) by ATIV and match them to different patterns of immune responses and reactions to the vaccine. We will also assess the difference between these responses in children compared to adults.
To do this we will enrol healthy children aged 13 to 24 months and adults 18 years and over to receive ATIV. Children will receive 2 doses of the vaccine 28 days apart, and adults 1 dose. Participants will undergo blood tests to look at the
gene and immune responses and complete a diary to record any reactions to the vaccine.
The study will be conducted prior to and throughout the flu season in the UK, and participants will be recruited from the Thames Valley visits will be conducted at their homes or at the Oxford Vaccine Group.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0387
Date of REC Opinion
3 Sep 2015
REC opinion
Further Information Favourable Opinion