Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B
Condition: Prematurity; Vaccination; Meningococcal Disease
MeSH terms: Meningococcal Infections; Premature Birth
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This will be an open label, phase IV study. After appropriate consent, 132 premature infants
      born at <35 weeks gestation (i.e. up to 34 weeks and 6 days), 50% <30 weeks gestation (i.e.
      up to 29 weeks and 6 days) will be randomised to 1 of 2 4CMen B schedules either at 2,4 and
      12 months or 2,3,4 and 12 months. Babies will remain in the study for around 12 months, from
      recruitment to 13 months of age. All visits can be performed at the participant's home or in
      clinic, depending on the preference of the parents and study team.

      Blood samples will be obtained at 5 months of age (post primary sample), 12 months
      (persistence sample) and 13 months (post booster sample). Reactogenicity and safety will be
      assessed by caregiver completion of a 7-day diary after each vaccine dose. Inpatients will be
      monitored for cardiorespiratory events for 72 hours after vaccination by healthcare staff and
      this information will be collected on the CRF. This will include details of oxygen
      saturations, heart rate, respiratory rate and details of any episodes of desaturation,
      bradycardia or apnoea. Particular emphasis will be placed on rates, timing and intensity of
      fever and other adverse reactions in the first 24 hours after vaccination, because this
      remains a cause of great concern amongst neonatologists.
    

Intervention name(s): 4CMenB Vaccine; 4CMenB Vaccine; 4CMenB Vaccine; 4CMenB Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months; The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months; The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months; The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
Other intervention name(s): Bexsero; Bexsero; Bexsero; Bexsero
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be an open label, phase IV study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prematurity; Vaccination