LionMenB – earLy protectIOn agaiNst Meningococcal B disease in infants

Phase IV randomisation study of different Men B vaccine primary immunisation schedules in UK infants

Open to recruitment

Phase IV randomisation study of different Men B vaccine primary immunisation schedules in UK infants

Aim of the study: This study is being undertaken to compare the immune responses of UK infants who receive their routine immunisations alongside two different 4CMenB primary immunisation schedules. Completing the primary 4CMenB schedule by 3 months could provide infants earlier protection against MenB disease since cases peak at 5 months of age and remain high in the second half of the first year before starting to decline (Ladhani et al., 2012). If this clinical trial shows comparable immunogenicity for the main 4CMenB antigens using the two different schedules, then the results could change UK national immunisation policy to offer infants earlier protection against this devastating disease and could potentially be adopted by other countries worldwide.

Inclusion and exclusion criteria:

Inclusion:

  • Term infants born at ≥37 weeks gestation
  • Aged ≥56 days to ≤ 70 days on the day of first visit
  • No contraindications to vaccination according to the ‘Green Book’
  • Willing and able to comply with study procedures
  • Written informed consent

Exclusion:

  • Contraindication to vaccination according to the Green Book
  • Life-limiting congenital abnormality or condition
  • Prior diagnosis of an immunodeficiency syndrome
  • Previous vaccination against meningococcal disease
  • History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
  • Considered unlikely to complete expected follow up until the end of the study
  • Child in care

What participating in the study involves?:

After you have signed the consent form, your baby will be randomly (like tossing a coin) assigned to one of two groups: one group (Group 2) will receive all recommended vaccines according to the standard UK schedule and the other (Group 1) will receive the vaccines with a slight adjustment to the order – the second dose of Men B vaccine at 3 instead of 4 months and the first dose of PCV13 at 4 instead of 3 months. Your baby will have a 50:50 chance of being in each group. There are no extra or new vaccines being used in the study.

If you agree for your baby to participate, you will be asked to sign a consent form. After every vaccination visit, you will be given a diary card to complete, which will be collected at the following visit. Your study doctor or nurse will explain how to fill in the diary. The diary card will be used to record daily temperatures and any redness or swelling that may occur around the injection site, for up to 7 days after each vaccination. A thermometer and a tape measure will be provided, along with a telephone number to contact the on-call doctor from our team at any time if you have concerns about your baby.  We will also ask you to let us know by telephone if your baby has been unwell during the 28 days after immunisation, even if the illness seems unrelated to the vaccination. If you have to visit a doctor for the illness, we may contact them for further information. We will request your permission for study staff to ask your GP for your contact details if we lose contact with you during the study.

If you would like to find out more, please read the Study Information Booklet and if you are interested in taking part, please complete our pre-screening questionnaire. Once the sites is open, you will be contacted and given a local information sheet.

Parent Information Sheet