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

NCT03125616 | Completed Phase 4

• 2 other identifiers: 16.02472017-001487-38
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; Vaccination; Meningococcal Disease

Keywords

Prematurity; Vaccination

Outcome Measures

Primary Outcomes (2)

• hSBA GMT

  hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA

  Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)

• hSBA proportions

  hSBA proportions ≥ 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

  Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)

Secondary Outcomes (9)

• Reactions within 7 days

  Assessed in each infant for the 7 days following vaccination

• Cardiorespiratory status for 72 hours following vaccination

  Assessed in all infants in hospital for 72 hours following vaccination

• Suspicion of sepsis in 7 days following vaccination

  Assessed in all infants in the 7 days following vaccination

• Fever and/or suspicion of sepsis in the 28 days following vaccination

  Assessed in all infants in the 28 days following vaccination

• Serious adverse events

  Assessed in all infants at the conclusion of the study

Study Arms (2)

Standard UK 4CMenB vaccine

ACTIVE COMPARATOR

4CMenB (Bexsero®) vaccination at 2 and 4 months and a booster at 12 months .

Biological: 4CMenB Vaccine

Additional 4CMenB Vaccine

EXPERIMENTAL

4CMenB (Bexsero®) vaccination at 2, 3 and 4 months and a booster at 12 months.

Biological: 4CMenB Vaccine

Interventions

4CMenB Vaccine BIOLOGICAL

The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months

Also known as: Bexsero

Additional 4CMenB Vaccine; Standard UK 4CMenB vaccine

Eligibility Criteria

• Age: 7 Weeks - 11 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infant born at \<35 weeks gestation
• No contraindications to vaccination according to the 'Green Book'
• Willing and able to comply with study procedures
• Written informed consent

You may not qualify if:

• Contraindication to vaccination according to the Green Book
• Life-limiting congenital abnormality or condition
• Prior diagnosis of an immunodeficiency syndrome
• Considered unlikely to complete expected follow up until the end of the study

Sponsors & Collaborators

• St George's, University of London: lead
• GlaxoSmithKline: collaborator
• MeningitisNow: collaborator
• Public Health England: collaborator

Study Sites (1)

St Georges University Hospital NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40652683 DERIVED

• 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.

  PMID: 38977298 DERIVED

Related Links

• Meningococcal: the green book, chapter 22

MeSH Terms

Conditions

Premature Birth; Meningococcal Infections

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Paul Heath, MBBS

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be an open label, phase IV study.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: August 1, 2017
• Primary Completion: September 2, 2019
• Study Completion: August 28, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)