The 6-in-1 Vaccine Study
Research type
Research Study
Full title
Immunogenicity and reactogenicity of concomitantly administered hexavalent and Group B meningococcal vaccines in infancy.
IRAS ID
252324
Contact name
Matthew Snape
Contact email
Sponsor organisation
Clinical Trials and Research Governance (CTRG)
Eudract number
2018-003451-38
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Summary of Research
In 2017 the hepatitis B vaccine was added to the UK routine immunisation programme. An infection with the hepatitis B virus can cause severe inflammation of the liver and can cause severe long term damage to the liver. To allow the introduction of the Hepatitis B vaccine to the UK’s childhood immunisation schedule without increasing the number of vaccine injections, the previously used ‘5-in-1’ vaccine was replaced by a ‘6-in-1’ vaccine which protects against diphtheria, tetanus, poliovirus, whooping cough (pertussis), hepatitis B and haemophilus influenza B (Hib). There are two licensed ‘6-in-1’ vaccines available and these are 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 studies that this vaccine works well with the other vaccines in the UK schedule, including the meningocococcal B vaccine (MenB, Bexsero), in that it is able to induce a good immune response to all vaccine components and has an acceptable side effect profile. 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-H and is just as safe when given in the immunisation schedule along with the MenB vaccine, the NHS will potentially be able to use either vaccine for children in the UK, increasing the flexibility and resilience of the routine immunisation schedule.
To do this we will enrol 240 infants 8 to 13 weeks of age, and randomise to receive either 6 in 1-IH or 6 in 1-V along with the routine infant UK immunisation schedule. Blood test will be taken at 5 and 13 months of age to check the immune responses to these vaccines.
Summary of Results
The summary results present data from the first immunogenicity and reactogenicity study comparing two hexavalent vaccines administered in infancy alongside 4CMenB. These demonstrate non-inferiority of Vaxelis compared to Infanrix Hexa for Hib immunogenicity, with anti-PRP IgG GMCs over 20-fold higher at 5 months after Vaxelis than Infanrix Hexa. No increase in reactogenicity was observed, supporting the introduction of Vaxelis as an alternative to Infanrix Hexa in the routine childhood immunization schedule of the UK and other countries deploying 4CMenB in infancy.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0052
Date of REC Opinion
21 Feb 2019
REC opinion
Favourable Opinion