The 6-in-1 vaccine study

What is the study about? In 2017 the hepatitis B vaccine was added to the UK routine immunisation programme in the form of the ‘6-in-1’ vaccine, immunising against diphtheria, tetanus, pertussis (whooping cough), poliovirus, Haemophilus influenzae b and hepatitis B virus. There are currently two licensed 6-in-1 vaccines called Infanrix hexa (6 in 1(IH)) and Vaxelis (6 in 1(V)). 6 in 1(IH) is currently used routinely in the UK. We know from previous research studies that this vaccine works well with the other vaccines in the UK schedule, including the meningococcal B vaccine (MenB, Bexsero). At present we do not have this information for the 6 in 1(V) vaccine.

If we can show that immunisation with 6 in 1(V) induces a similar immune response to 6 in 1(IH) and is just as safe when given along with the MenB vaccine, the NHS would potentially be able to use either vaccine for children in the UK, increasing the flexibility and resilience of the routine immunisation schedule.

What happens in the study? Children will receive their routine vaccines according to the UK immunisation schedule. Participants will be randomised to receive either the licensed 6-in-1 vaccine called Infanrix hexa (6 in 1(IH)) or Vaxelis (6 in 1(V)). Each child will have two blood tests during the duration of the study.

Who can be involved? The Oxford Vaccine Group (University of Oxford) is inviting children aged 8 to 13 weeks of age who have not yet had their 8 week immunisations to take part in the study.

What can I do if I’m interested in taking part? If you would like further information about the study please contact the study team:

Before you decide whether your child should take part, it is important for you to understand exactly what the study is about and what participation would involve. Participation in the study is voluntary and if enrolled your child may withdraw at any time.

If you are interested in this study, the full information booklet is available HERE .

If you would like to discuss any aspect of the study please contact the study by email or phone:

Email info@ovg.ox.ac.uk, Tel: 01865 611400

Many thanks,

The Oxford Vaccine Group