Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B

Summary

In the UK, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. This policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK schedule in September 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. The Investigators want to compare two different schedules of 4CMenB and see if one gives better protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. This is what the Investigators are trying to find out through this study.

Timeline

Start

2017-08-01

Primary completion

2019-09-02

Completion

2020-08-28

Publications

• Daniel O, Srikanth S, Clarke P, Le Doare K, Heath PT, Jones CE, Scorrer T, Snape M, Calvert A. Pertussis antibody responses in infants born to mothers vaccinated at different time points in pregnancy. Vaccine. 2025 Aug 30;62:127481. doi: 10.1016/j.vaccine.2025.127481. Epub 2025 Jul 12.
• Calvert A, Andrews N, Barlow S, Borrow R, Black C, Bromage B, Carr J, Clarke P, Collinson AC, Few K, Hayward N, Jones CE, Le Doare K, Ladhani SN, Louth J, Papadopoulou G, Pople M, Scorrer T, Snape MD, Heath PT. An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants. Arch Dis Child. 2024 Oct 18;109(11):898-904. doi: 10.1136/archdischild-2024-327040.

Drugs

Indications