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

NCT ID: NCT03125616

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-08-28

Brief Summary

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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

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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.

Conditions

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Prematurity Vaccination Meningococcal Disease

Keywords

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Prematurity Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be an open label, phase IV study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard UK 4CMenB vaccine

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

Group Type ACTIVE_COMPARATOR

4CMenB Vaccine

Intervention Type BIOLOGICAL

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

4CMenB Vaccine

Intervention Type BIOLOGICAL

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

4CMenB Vaccine

Intervention Type BIOLOGICAL

The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months

Additional 4CMenB Vaccine

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

Group Type EXPERIMENTAL

4CMenB Vaccine

Intervention Type BIOLOGICAL

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

4CMenB Vaccine

Intervention Type BIOLOGICAL

The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months

4CMenB Vaccine

Intervention Type BIOLOGICAL

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

4CMenB Vaccine

Intervention Type BIOLOGICAL

The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months

Interventions

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4CMenB Vaccine

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

Intervention Type BIOLOGICAL

4CMenB Vaccine

The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months

Intervention Type BIOLOGICAL

4CMenB Vaccine

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

Intervention Type BIOLOGICAL

4CMenB Vaccine

The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months

Intervention Type BIOLOGICAL

Other Intervention Names

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Bexsero Bexsero Bexsero Bexsero

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

7 Weeks

Maximum Eligible Age

11 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

MeningitisNow

UNKNOWN

Sponsor Role collaborator

Public Health England

OTHER_GOV

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Heath, MBBS

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

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St Georges University Hospital NHS Foundation Trust

Tooting, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40652683 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38977298 (View on PubMed)

Related Links

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https://www.gov.uk/government/publications/meningococcal-the-green-book-chapter-22

Meningococcal: the green book, chapter 22

Other Identifiers

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2017-001487-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16.0247

Identifier Type: -

Identifier Source: org_study_id