AzTrials
AzTrials

PrematurityPhase 4BEAR Men BNCT03125616

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

A Phase 4 study testing 4CMenB Vaccine in people with Prematurity and Vaccination, run by St George's, University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 11 weeks
Conditions the study is for
Prematurity, Vaccination, Meningococcal Disease
What is being tested?
4CMenB Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2017to 28 Aug 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • St Georges University Hospital NHS Foundation Trust

    Tooting, London, SW17 0QT

Other trials in United Kingdom

About this study

Official title: Babies Born Early Antibody Response to Men B Vaccination: A Phase IV Multicentre Randomised Study to Evaluate the Primary and Booster Immune Responses in UK Preterm Infants Receiving Routine Immunisations and Incorporating a Three Dose Versus a Two Dose Schedule of 4CMenB (Bexsero®) for Primary Immunisation.

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.

Read the 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.

Being tested
4CMenB Vaccine
Keywords
Prematurity, Vaccination
Medical subject headings
Premature Birth, Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4CMenB VaccineBiological

    Also called Bexsero

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

  • 4CMenB VaccineBiological

    Also called Bexsero

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

  • 4CMenB VaccineBiological

    Also called Bexsero

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

  • 4CMenB VaccineBiological

    Also called Bexsero

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

Study groups in NCT03125616
Study groupRoleWhat they receive
Standard UK 4CMenB vaccineActive comparator4CMenB (Bexsero®) vaccination at 2 and 4 months and a booster at 12 months .
Receives: Biological: 4CMenB Vaccine
Additional 4CMenB VaccineExperimental4CMenB (Bexsero®) vaccination at 2, 3 and 4 months and a booster at 12 months.
Receives: Biological: 4CMenB Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hSBA GMT

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

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

  2. hSBA proportions

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

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

Secondary outcomes (9)

  1. Reactions within 7 days

    The percentage of infants experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose

    Measured: Assessed in each infant for the 7 days following vaccination

  2. Cardiorespiratory status for 72 hours following vaccination

    The percentage of inpatients experiencing change / deterioration in cardiorespiratory status within the 72 hours following each vaccine dose

    Measured: Assessed in all infants in hospital for 72 hours following vaccination

  3. Suspicion of sepsis in 7 days following vaccination

    The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination

    Measured: Assessed in all infants in the 7 days following vaccination

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

    The percentage of infants who experience fever and/or are investigated for sepsis and commenced on antibiotics within 28 days of vaccination

    Measured: Assessed in all infants in the 28 days following vaccination

  5. Serious adverse events

    The percentage of infants who experience a serious adverse event at any point within the study

    Measured: Assessed in all infants at the conclusion of the study

  6. Persistence of hSBA GMTs

    hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA

    Measured: Assessed in all infants at 12 months of age

  7. Persistence of hSBA proportions ≥1:4

    hSBA proportions ≥1:4, at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA

    Measured: Assessed in all infants at 12 months of age

  8. Booster response: hSBA GMTs

    hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA;

    Measured: Assessed in all infants at 13 months of age

  9. Booster response: hSBA proportions ≥1:4

    hSBA proportions ≥1:4, at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

    Measured: Assessed in all infants at 13 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start1 Aug 2017
  3. Primary completion2 Sep 2019
  4. Study completion28 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be an open label, phase IV study.
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03125616
Sponsor's protocol ID
16.0247
Other IDs
2017-001487-38, 2017
Acronym
BEAR Men B
Status last verified
Nov 2020
First submitted
19 Apr 2017
Last updated
1 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers.

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.

    PubMed 40652683

  • 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.

    PubMed 38977298

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 4CMenB Vaccine in people with Prematurity and Vaccination, run by St George's, University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hSBA GMT (time frame: Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03125616, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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